Career Opportunities
Job purpose
To perform medical review and oversight of processing for all types of safety events, and other medically-related project information. Provide medical oversight and completion of analysis of similar events, company causality assessment, and expectedness assessment, review of MedDRA coding, causality assessment signal detection, risk management, and pharmacovigilance oversight for assigned projects.
Duties and responsibilities
- Reviewing and analyzing adverse event reports, clinical trial data, and other safety information related to drugs.
- Identifying and assessing safety risks associated with drugs, and making recommendations for managing or mitigating those risks.
- Communicating safety information to regulatory agencies, healthcare professionals, and the general public.
- Collaborating with other members of the drug development team, including pharmacologists, toxicologists, and statisticians, to ensure that safety issues are adequately addressed.
- Participating in the development of risk management plans, which outline strategies for minimizing the risk of adverse events associated with drugs.
- Reviewing and approving of protocol for clinical trial safety and contributing to the report of clinical trial safety.
- Staying up-to-date with the latest developments in drug safety, including new regulations and guidelines, to ensure that safety evaluations are conducted in accordance with the latest standards.
- Reviewing and evaluating the safety and efficacy of new drug candidates during the development and approval process.
- Participating in the design and conduct of clinical trials to ensure that safety and efficacy data are collected and analyzed appropriately.
- Collaborating with other departments within the company, such as research and development, regulatory affairs, and marketing, to ensure that safety and efficacy data are communicated effectively to internal and external stakeholders.
- Contributing to the preparation of regulatory submissions and responding to questions from regulatory agencies regarding the safety and efficacy of drugs.
- Providing medical expertise and guidance to other members of the company, such as sales and marketing teams, to ensure that the appropriate safety information is communicated to healthcare professionals and patients.
- Participating in ongoing safety surveillance programs to monitor the safety of drugs once they are on the market.
- Being responsible for the overall safety of the drug, from preclinical development to post-approval.
Education & Experience
- Bachelor's or Master’s degree in Medical or Dental Sciences
- Previous experience that provides the knowledge, skills, and abilities to perform the job (3+ years’).
- Experience working in the pharmaceutical/CRO industry preferred
Knowledge, Skills and Abilities
- Excellent technical data interpretation skills
- Strong understanding of Medical Sciences
- Excellent interpersonal skills including problem solving
- Strong negotiation skills
- Excellent oral and written communication skills with strong presentation skills
- Significant knowledge of global, regional, national and other document development guidelines
- In-depth knowledge in a specialty area such as preclinical, therapeutic, regulatory submissions, communications, etc.
- Great judgment and decision-making skills
- Excellent computer skills and skilled with client templates; Good knowledge of document management systems and other relevant applications (e.g. Excel, Outlook)
- Ability and desire to work in a team-oriented environment.
- Excellent written and verbal communication skills
- Highly proficient with Microsoft Word, PowerPoint and Excel.
- Demonstrates ability to evaluate information and data with a defined, studied process and report results in a thoughtful, organized manner
- Possesses a collaborative, results-driven style.
- Flexible, Adaptive, Ability to work under pressure and provide quality outputs within tight timelines
Other requirements
As may be required from time to time – the incumbent may be required to working slots catering to different time zones
Job purpose To perform medical review and oversight of processing for all types of safety events, and other medically-related project information. Provide medical oversight and completion of analysis ...
Job Descriptions
- CMC review of technical documentation for regulatory filings to various markets – market: US- Gap Analysis and Remediation for module 3 -CMC
- Development and implementation of regulatory strategies, processes and timelines for grant of MA- Africas, GCC, LATAM, ASEAN.
- Review of CTD dossiers , variations, change controls, renewals and ensuring that they are in conformance with applicable regulatory guidelines and that the highest quality standards are met.
- Critically reviews documentation intended for submission to the respective agencies for internal consistency, for consistency to relevant guidelines and to promote regulatory excellence.
- Demonstrate subject matter and area expertise.
- Collaborate with internal and external clients,
- Supporting and enabling effective and efficient communication that results in operational excellence.
- Demonstrate high level knowledge of country regulations and regulatory guidelines as updated from time to time on various agencies’ website.
Education & Experience
- Master’s degree in Pharma
- Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 7 to 10 years’) or equivalent combination of education, training, & experience.
Knowledge, Skills and Abilities
- Excellent technical data interpretation skills
- Excellent interpersonal skills including problem solving
- Excellent oral and written communication skills with strong presentation skills
- Significant knowledge of US Regulations
- Excellent computer skills; Good knowledge of document management systems and other relevant applications (e.g. Excel, Outlook)
- Ability and desire to work in a team-oriented environment.
- Excellent written and verbal communication skills
- Highly proficient with Microsoft Word, PowerPoint and Excel.
- Possesses a collaborative, results-driven style.
- Flexible, Adaptive, Ability to work under pressure and provide quality outputs within tight timelines
Other requirements
As may be required from time to time – the incumbent may be required to working slots catering to different time zones
Location
Gurgaon, Haryana (INDIA)
Job Descriptions CMC review of technical documentation for regulatory filings to various markets – market: US- Gap Analysis and Remediation for module 3 -CMC Development and implementation of regula...
Job Title: Assistant Manager – Regulatory Affairs (EU & UK)
Location: Gurgaon, Haryana (India)
Experience: 4–6 Years
Qualification: Master’s Degree in Pharmacy (M.Pharm or equivalent)
Role Overview
We are seeking a proactive and detail-oriented Assistant Manager – Regulatory Affairs to join our Global Regulatory team. The ideal candidate will be responsible for driving CMC documentation, regulatory submissions, and lifecycle management for the EU & UK markets, ensuring compliance with regional and international guidelines.
Key Responsibilities
Conduct comprehensive CMC reviews of technical documentation for regulatory filings across the EU and UK markets.
Perform Gap Analysis and Remediation for Module 3 (CMC) sections to ensure submission readiness and alignment with regulatory standards.
Develop and implement regulatory strategies, processes, and timelines for the preparation and submission of Marketing Authorization (MA) applications.
Prepare and compile new CTD dossiers, variations, and renewals ensuring full compliance with applicable EMA/MHRA regulatory requirements and internal quality standards.
Critically review documentation to ensure internal consistency, compliance with regulatory expectations, and support regulatory excellence.
Collaborate with cross-functional teams including R&D, QA, QC, Manufacturing, and external stakeholders for timely and accurate data collation and submissions.
Ensure effective and efficient communication across teams to facilitate streamlined project execution and meet submission timelines.
Maintain high-level knowledge of current country-specific regulations, keeping track of regulatory updates through respective health authority websites (e.g., EMA, MHRA).
Education & Experience
Master’s degree in Pharmacy or equivalent qualification.
4 to 6 years of relevant experience in Regulatory Affairs, with a focus on EU and/or UK submissions.
Equivalent combinations of education, training, and practical experience may also be considered.
Key Skills & Competencies
Strong technical skills in data analysis and interpretation of regulatory documentation.
Excellent interpersonal and problem-solving skills with a proactive and solution-oriented approach.
Effective negotiation and communication skills for liaising with internal teams and external agencies.
Proficient in drafting and reviewing documents in line with global, regional, and national regulatory standards.
Expertise in document management systems and tools like Excel, Outlook, PowerPoint, and Word.
Strong presentation and reporting skills with the ability to explain complex regulatory concepts clearly.
Demonstrated ability to analyze data systematically, apply regulatory logic, and compile well-organized submissions.
Collaborative, results-driven, and self-motivated with the flexibility to adapt to shifting priorities.
Capable of delivering high-quality outputs under pressure and within aggressive timelines.
Other Requirements
Flexibility to work in cross-time-zone schedules, as needed to support global project coordination or agency interactions.
Why Join Us?
Be part of a high-performing regulatory team that plays a critical role in bringing impactful pharmaceutical products to patients globally. Work in a collaborative, fast-paced environment where your expertise shapes international market access strategies.
Job Title: Assistant Manager – Regulatory Affairs (EU & UK) Location: Gurgaon, Haryana (India) Experience: 4–6 Years Qualification: Master’s Degree in Pharmacy (M.Pharm or equivalent) Rol...
Job Descriptions
- CMC review of technical documentation for regulatory filings to various markets – market: US- Gap Analysis and Remediation for module 3 -CMC
- Development and implementation of regulatory strategies, processes and timelines for grant of ANDAs.
- Prepares and compiles new ANDAs, Amendments, Supplements, Annual Reports, 505(b)(2) and 505(b)(1) filings ensuring that they are in conformance with applicable regulatory guidelines and that the highest quality standards are met.
- Critically reviews documentation intended for submission to the respective agencies for internal consistency, for consistency to relevant guidelines and to promote regulatory excellence.
- Demonstrate subject matter and area expertise.
- Collaborate with internal and external clients,
- Supporting and enabling effective and efficient communication that results in operational excellence.
- Demonstrate high level knowledge of country regulations and regulatory guidelines as updated from time to time on various agencies’ website.
Education & Experience
- Master’s degree in Pharma
- Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 4 to 6 years’) or equivalent combination of education, training, & experience.
Knowledge, Skills and Abilities
- Excellent technical data interpretation skills
- Excellent interpersonal skills including problem solving
- Excellent oral and written communication skills with strong presentation skills
- Significant knowledge of US Regulations
- Excellent computer skills; Good knowledge of document management systems and other relevant applications (e.g. Excel, Outlook)
- Ability and desire to work in a team-oriented environment.
- Excellent written and verbal communication skills
- Highly proficient with Microsoft Word, PowerPoint and Excel.
- Possesses a collaborative, results-driven style.
- Flexible, Adaptive, Ability to work under pressure and provide quality outputs within tight timelines
Other requirements
As may be required from time to time – the incumbent may be required to working slots catering to different time zones
Location
Gurgaon, Haryana (INDIA)
Job Descriptions CMC review of technical documentation for regulatory filings to various markets – market: US- Gap Analysis and Remediation for module 3 -CMC Development and implementation of regula...
Job Descriptions
- CMC review of technical documentation for regulatory filings to various markets – market: EU & UK, US- Gap Analysis and Remediation for module 3 -API
- Prepare and compile Section 322, QOS & QbR ensuring that they are in conformance with applicable regulatory guidelines and that the highest quality standards are met.
- Critically reviews documentation intended for submission to the respective agencies for internal consistency, for consistency to relevant guidelines and to promote regulatory excellence.
- Demonstrate subject matter and area expertise.
- Collaborate with internal and external clients,
- Supporting and enabling effective and efficient communication that results in operational excellence.
- Demonstrate high level knowledge of country regulations and regulatory guidelines as updated from time to time on various agencies’ website.
Education & Experience
- Master’s degree in Pharma, Msc Chemistry
- Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 4 to 6 years’) or equivalent combination of education, training, & experience.
Knowledge, Skills and Abilities
- Excellent technical data interpretation skills
- Excellent interpersonal skills including problem solving
- Strong negotiation skills
- Excellent oral and written communication skills with strong presentation skills
- Significant knowledge of global, regional, national and other document development guidelines
- Excellent computer skills; Good knowledge of document management systems and other relevant applications (e.g. Excel, Outlook)
- Ability and desire to work in a team-oriented environment.
- Excellent written and verbal communication skills
- Highly proficient with Microsoft Word, PowerPoint and Excel.
- Demonstrates ability to evaluate information and data with a defined, studied process and report results in a thoughtful, organized manner
- Possesses a collaborative, results-driven style.
- Flexible, Adaptive, Ability to work under pressure and provide quality outputs within tight timelines
Other requirements
As may be required from time to time – the incumbent may be required to working slots catering to different time zones
Location
Gurgaon, Haryana (INDIA)
Job Descriptions CMC review of technical documentation for regulatory filings to various markets – market: EU & UK, US- Gap Analysis and Remediation for module 3 -API Prepare and compile Section...
Job purpose
To Manage Regulatory Affairs for in compliance to applicable regulations and guidelines. This position will assist with the review of clinical/Biopharmaceutical/Non Clinical and labelling documentation, preparation and review of non-CMC sections, Variations, site transfers and post approval gap analysis. This position will also provide support of the regulatory function through document management, electronic submission compilation and management, and other group management activities as required. Position will be required to work with Regulatory Affairs, Quality Assurance, Quality Control, Manufacturing, Research and Development groups of the client organization of DDReg.
Duties and responsibilities
- Providing high-quality Clinical, Biopharmaceutical, Pharmacokinetic, non-clinical review of CTD sections for regulatory filings to SRA (e.g EMA, UK MHRA, National Agencies of EU Member states, Canada, Australia) as well as agencies of ROW markets for DDReg clients
- Actively contribute to the development and implementation of regulatory strategies, processes and timelines for global approval.
- Carrying out Gap Analysis of Non-CMC sections for small molecules and biopharmaceuticals
- Authoring, and compiling CTDs sections, Variations (Major/Minor/Site Transfers) filings ensuring that they are in conformance with applicable regulatory guidelines and that the highest quality standards are met.
- Prepare &/or review labelling documentation, managing labelling changes, prepare variation application on labelling changes, intended for submission to the above-mentioned agencies, internal consistency, for consistency to relevant guidelines and to promote regulatory excellence.
- Demonstrate subject matter and area expertise. Collaborate with internal and external clients.
- Supporting and enabling effective and efficient communication that results in operational excellence.
- Providing technical consultation and provides substantive advice on strategy, regulations and industry best practices.
- Demonstrate high level knowledge of country regulations and regulatory guidelines as updated from time to time on agencies website.
- Monitor competitive regulatory practices and actively review internal and external factors to mitigate potential problems.
- Ensure that draft labeling complies with all applicable regulations and guidelines
Education & Experience
- Bachelor's or Master’s degree in Pharma
- Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 5+ years’) or equivalent combination of education, training, & experience.
- Experience working in the pharmaceutical/CRO industry preferred
Knowledge, Skills and Abilities
- Excellent technical data interpretation skills
- Strong project management skills
- Excellent interpersonal skills including problem solving
- Excellent oral and written communication skills with strong presentation skills
- Significant knowledge of global, regional, national and other document development guidelines
- In-depth knowledge in a specialty area such as preclinical, therapeutic, regulatory submissions, communications, etc.
- Great judgment and decision-making skills
- Excellent computer skills and skilled with client templates; Good knowledge of document management systems and other relevant applications (e.g. Excel, Outlook)
- Ability and desire to work in a team-oriented environment.
- Excellent written and verbal communication skills
- Highly proficient with Microsoft Word, PowerPoint and Excel.
- Demonstrates ability to evaluate information and data with a defined, studied process and report results in a thoughtful, organized manner
- Possesses a collaborative, results-driven style.
- Flexible, Adaptive, Ability to work under pressure and provide quality outputs within tight timelines
Other requirements
As may be required from time to time – the incumbent may be required to working slots catering to different time zones
Location
Gurgaon, Haryana (INDIA)
Job purpose To Manage Regulatory Affairs for in compliance to applicable regulations and guidelines. This position will assist with the review of clinical/Biopharmaceutical/Non Clinical and labelling ...
Job Description
| Job title | AGM/Senior Manager |
| Reports to | Director |
Job purpose
To Manage Regulatory Affairs for Emerging (RoW) Markets/Regulated Markets (Eu/US/Canada/Japan/UK/Australia) in compliance to applicable regulations and guidelines. The responsibility include review of technical documents/dossiers, preparation and submission of Submission dossiers in CTD format, ePublish them (wherever applicable), response to queries, post approval life cycle management etc. This position will also provide support of the regulatory function through document management, electronic submission compilation and management, and other group management activities as required. Position will be required to work with Regulatory Affairs, Quality Assurance, Quality Control, Manufacturing, Research and Development groups of the client organization of DDReg.
Duties and responsibilities
- Providing high-quality CMC review of technical documentation for regulatory filings to various markets – key market being Saudi & GCC, for DDReg clients
- Actively contribute to the development and implementation of regulatory strategies, processes and timelines for grant of MAs.
- Prepares and compiles new CTD dossiers, renewals and variations ensuring that they are in conformance with applicable regulatory guidelines and that the highest quality standards are met.
- Critically reviews documentation intended for submission to the respective agencies for internal consistency, for consistency to relevant guidelines and to promote regulatory excellence.
- Demonstrate subject matter and area expertise.
- Collaborate with internal and external clients,
- Supporting and enabling effective and efficient communication that results in operational excellence.
- Manage multiple projects with the help of team, track the status of each project, provide update to management in a time bound manner, monitor efficiency of team members.
- Providing technical consultation and provides substantive advice on strategy, regulations and industry best practices.
- Demonstrate high level knowledge of country regulations and regulatory guidelines as updated from time to time on various agencies’ website.
- Monitor competitive regulatory practices, and actively review internal and external factors to mitigate potential problems.
- Ensure that draft labeling complies with all applicable regulations and guidelines
Education & Experience
- Bachelor's or Master’s degree in Pharma
- Previous experience of minimum 7 years that provides the knowledge, skills, and abilities to perform the job.
Knowledge, Skills and Abilities
- Excellent technical data interpretation skills
- Strong project management skills
- Excellent interpersonal skills including problem solving
- Strong negotiation skills
- Excellent oral and written communication skills with strong presentation skills
- Significant knowledge of global, regional, national and other document development guidelines
- In-depth knowledge in a specialty area such as preclinical, therapeutic, regulatory submissions, communications, etc.
- Great judgment and decision-making skills
- Excellent computer skills and skilled with client templates; Good knowledge of document management systems and other relevant applications (e.g. Excel, Outlook)
- Ability and desire to work in a team-oriented environment.
- Excellent written and verbal communication skills
- Highly proficient with Microsoft Word, PowerPoint and Excel.
- Demonstrates ability to evaluate information and data with a defined, studied process and report results in a thoughtful, organized manner
- Possesses a collaborative, results-driven style.
- Flexible, Adaptive, Ability to work under pressure and provide quality outputs within tight timelines
Other requirements
As may be required from time to time – the incumbent may be required to working slots catering to different time zones
Location
Gurgaon, Haryana (INDIA)
Job Description Job title AGM/Senior Manager Reports to Director Job purpose To Manage Regulatory Affairs for Emerging (RoW) Markets/Regulated Markets (Eu/US/Canada/Japan/UK/Australia) in compliance...
Job Summary:
We are seeking a highly skilled and creative Graphic Designer & Videographer to join our in-house team in Gurgaon. This role is pivotal in shaping the visual identity of our pharmaceutical brand across all platforms. The ideal candidate will bring a strong balance of design expertise and technical proficiency in video production. You will be responsible for creating impactful graphics, marketing assets, scientific illustrations, and high-quality video content that aligns with our brand vision and supports both internal and external communications.
Key Responsibilities:
1. Branding & Identity Management
- Ensure consistent application of the company’s visual identity—including logos, typography, color schemes, and imagery—across digital and print media.
- Design brochures, internal documents, and promotional materials that reinforce brand integrity and professionalism.
2. Design for Marketing Campaigns
- Develop engaging visual assets for marketing campaigns, including brochures, posters, flyers, banners, and other promotional materials.
- Create digital creatives such as web banners, blog images, and social media posts to support online visibility and engagement.
3. Video Production & Editing
- Produce, shoot, and edit compelling video content for marketing campaigns, social media platforms, and the company website.
- Ensure all videos reflect brand tone and messaging while delivering visual storytelling that resonates with target audiences.
- Collaborate with marketing and content teams to conceptualize and storyboard creative video projects.
4. Website and Digital Design
- Partner with web developers to improve UI/UX and maintain a visually appealing, user-friendly website.
- Create infographics, visual data charts, and other content to communicate complex scientific and pharmaceutical information clearly.
5. Scientific and Medical Illustrations
- Design professional and visually clear scientific diagrams, illustrations, and infographics that simplify technical and medical data.
- Collaborate with subject matter experts to ensure visual accuracy and relevance for the pharmaceutical domain.
Required Skills and Qualifications: - Proven experience in graphic design and video production with a strong, diverse portfolio.
- Proficiency in Adobe Creative Suite (Photoshop, Illustrator, Premiere Pro, After Effects, etc.).
- In-depth understanding of branding, visual storytelling, and multimedia communication strategies.
- Experience working with UI/UX principles and collaborating with web development teams.
- Hands-on expertise in end-to-end video production (conceptualization, shooting, editing, post-production).
- Strong time management, organizational, and multitasking abilities.
- High attention to detail with a creative and problem-solving mindset.
Preferred Qualifications:
- Experience with motion graphics and animation.
- Background in designing for the pharmaceutical or healthcare industry is highly preferred.
Personal Attributes:
- Excellent communication and interpersonal skills.
- Innovative thinker with a passion for storytelling through visuals.
- Self-driven, able to work independently, and collaboratively with cross-functional teams.
- Strong team orientation with a proactive and solution-oriented approach.
Job Summary: We are seeking a highly skilled and creative Graphic Designer & Videographer to join our in-house team in Gurgaon. This role is pivotal in shaping the visual identity of our pharmaceu...
About Us:
We are life sciences company specializing in pharmaceutical regulatory solutions, leveraging AI to tackle complex data challenges in specialized fields.
Job Requirements:
We are looking for a versatile Machine Learning Engineer to lead NLP-driven projects and contribute to the development of foundational AI models for domain-specific applications. Job objective include designing and developing machine learning system in Pharma Life Science space, implementing appropriate ML algorithms, conducting experiments, and staying updated with the latest developments in the field.
Responsibilities:
- Develop and fine-tune machine learning models focused on text analysis, data extraction, and NLP tasks.
- Preprocess and structure large datasets, ensuring high quality and consistency.
- Design and implement efficient data pipelines to handle unstructured and semi-structured data sources.
- Work with data to create models, perform statistical analysis, and train and retrain systems to optimize performance. Their goal is to build efficient self-learning pharma Regulatory applications.
- Collaborate with cross-functional teams to integrate machine learning models into production environments, ensuring reliability and scalability.
- Continuously test, evaluate, and optimize model performance to meet project needs and user requirements.
Requirements:
- 2-4 year's experience in related field.
- Strong background in machine learning with a focus on NLP and text-based data processing.
- Proficiency in ML frameworks like PyTorch or TensorFlow, and experience with NLP libraries such as Hugging Face Transformers or SpaCy.
- Solid understanding of data wrangling, feature engineering, and preparing datasets for model training.
- Knowledge of NLP models such as BERT, GPT family, Transformers, etc.
- Hands-on experience with deploying and optimizing machine learning models for production use.
- Knowledge of cloud platforms (AWS, GCP, Azure) and version control systems like Git.
- Excellent problem-solving skills, a strong sense of ownership, and the ability to communicate complex concepts clearly.
About Us: We are life sciences company specializing in pharmaceutical regulatory solutions, leveraging AI to tackle complex data challenges in specialized fields. Job Requirements: We are looking for ...
Job Summary:
We are seeking a highly skilled and technically sound Senior Full-Stack Engineer with 4–6 years of hands-on experience in the MERN stack (MongoDB, Express.js, React.js, Node.js). This role is ideal for a candidate who thrives in a fast-paced environment, possesses a strong command of both front-end and back-end technologies, and has the leadership capability to manage and mentor a multidisciplinary team.
The selected individual will work onsite from our Gurgaon office and report directly to the CTO, playing a strategic role in shaping and delivering scalable software solutions, including integrations with AI/ML modules.
Key Responsibilities:
- Architect, develop, and maintain end-to-end web applications using the MERN stack.
- Lead technical development of both client-side interfaces and server-side logic with a strong emphasis on performance, scalability, and security.
- Collaborate with UI/UX designers to convert Figma prototypes into responsive, interactive web applications.
- Coordinate and manage a team of software developers and collaborate with AI/ML engineers on feature integration.
- Translate business needs into technical solutions and contribute to system architecture and roadmap decisions alongside the CTO.
- Conduct code reviews, establish coding standards, and drive technical excellence within the development team.
- Optimize application performance at both the front-end and back-end levels.
- Troubleshoot production issues and ensure high system reliability and availability.
- Manage sprint planning, task assignments, and timely delivery of development milestones.
- Continuously explore and evaluate emerging tools and technologies to improve development efficiency and product quality.
Skills and Qualifications:
- Education: B.Tech / MCA / BCA or equivalent degree in Computer Science or related discipline.
- Experience: 4–6 years of full-stack development experience with a strong command of the MERN stack.
- Proven experience leading development teams and managing cross-functional technical projects.
- Strong front-end development skills using React.js and Next.js, with proficiency in modern JavaScript, HTML5, and CSS3.
- Back-end expertise in Node.js and Express.js, with experience in designing RESTful APIs.
- Solid hands-on experience with MongoDB for database design, indexing, and performance tuning.
- Strong grasp of Data Structures and Algorithms, with the ability to write optimized, maintainable code.
- Familiarity with UI/UX best practices and collaboration tools like Figma.
- Proficiency in Git and collaborative version control workflows.
- Excellent problem-solving skills and ability to manage multiple tasks with minimal supervision.
- Strong communication, interpersonal, and team management skills.
- Knowledge of cloud platforms such as AWS, GCP, or Azure is a plus.
Nice to Have:
- Experience with DevOps practices, CI/CD pipelines, and containerization tools like Docker.
- Familiarity with Agile/Scrum methodologies.
- Experience in AI/ML-based projects or integrating intelligent modules into full-stack applications.
What We Offer
- Opportunity to work closely with the CTO and contribute to key architectural and strategic decisions.
- A collaborative and fast-growing tech environment with real impact on product innovation.
- Career growth opportunities with leadership responsibilities.
- Competitive salary and performance-driven incentives.
Location Note:
This is a full-time, onsite role based in our Gurgaon office. Only candidates comfortable with working from the office should apply.
Job Summary: We are seeking a highly skilled and technically sound Senior Full-Stack Engineer with 4–6 years of hands-on experience in the MERN stack (MongoDB, Express.js, React.js, Node.js). This r...
Duties and responsibilities
- Managing overall finance functions including annual audits.
- Preparing financial reports e.g
- Revenue & Expense trends
- Working Capital sheets
- Cash flows, Balance sheets & PnLs.
- Manage Accounts payables & Receivables
- Manage Invoicing
- Manage GST & GST returns
- Preparing documentation and supporting Co CA with tax returns on time.
- Developing and implementing efficient internal controls, and adherence to accounting and other company policies and procedures.
- Month-end financial statements review and reporting to include variance analysis and account-level research.
- Supervise accounts and taxation
- Review daily operational performance, out-of-service, ancillary sales, payroll/productivity, revenue, and utilization performance.
- Perform, review, and approve required Internal Control Checklists. Ensure compliance with required policies and procedures through oversight and field training.
- Provide procurement support and controls through review and approval of all channels of spending. Ensure adherence to corporate procurement guidelines.
- Support annual budget planning
Qualification
- Bachelor’s Degree in Finance and/or Accountancy
- Having at least 3-5 years of relevant experience
- Good command of English
- Able to work independently
Preferred Professional Experience
- Proven track record in financial management to include accounting, financial planning, financial reporting, and internal controls.
- Knowledge:
- Strong Financial Planning and Analysis experience and application of metrics to drive performance.
- Financial and business acumen.
- Working knowledge of the service industry is desired.
Skills
- Strong communication skills required across a diverse cross-functional environment
- Ability to act as a change agent to drive process improvement
- Operate effectively within a complex and dynamic organization
- Ability to translate Corporate vision into results
- Strong Excel skills
- Ability to learn and operate numerous financial systems
Location: Gurgaon
Duties and responsibilities Managing overall finance functions including annual audits. Preparing financial reports e.g Revenue & Expense trends Working Capital sheets Cash flows, Balance sheet...
| Job title | Medical-Regulatory Writer – Assistant Manager |
| Reports to | Director |
- Providing high-quality medical and scientific writing from planning and coordination of literature search through delivery of final drafts to internal and external clients.
- Providing technical consultation and provides substantive advice on strategy, regulations and industry best practices.
- Demonstrate subject matter and therapeutic area expertise.
- Effectively manage medical writing projects to deliver quality products in agreed timelines.
- Collaborate with internal and external clients,
- Writing CTD Modules, Medical Data Packages, SmPCs, PIs, PILs, Safety Reports, Aggregate Reports and other reports
- Perform science review of aggregate reports produced by PV Associates
- Ensure that document output and processes comply with client specifications, templates and styles guidelines
- Attend project initiation meeting, collate project
- Maintain awareness of current regulatory guidance, medical information techniques and technology relating to clinical / regulatory documentation
- Maintain & update Aggregate Report Tracker and carry out cases reconciliation on periodic basis
- Supporting and enabling effective and efficient communication that results in operational excellence.
- Carry out detailed searches in regulatory agency websites like US FDA, EMA, PMDA, TGA, UKMHRA etc for safety alerts
- Mentor Associates on job skills, oversees or develops training plans or materials for safety associates, conducts training sessions, or otherwise trains new hires and enhances the skills of existing
- Master’s degree in a Pharmacology/Pharmacy/Medicine with 5 years Experience
- Advanced degree preferred
- Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 3+ years’) or equivalent combination of education, training, & experience.
- Experience working in the pharmaceutical/CRO industry preferred
- Additional qualifications in medical writing (AMWA; EMWA; RAC) advantageous
- Excellent data interpretation and medical writing skills, including grammatical, editorial, and proofreading skills
- Strong project management skills
- Excellent interpersonal skills including problem solving
- Strong negotiation skills
- Excellent oral and written communication skills with strong presentation skills
- Significant knowledge of global, regional, national and other document development guidelines
- In-depth knowledge in a specialty area such as preclinical, therapeutic, regulatory submissions, communications, etc.
- Great judgment and decision-making skills
- Excellent computer skills and skilled with client templates; Good knowledge of document management systems and other relevant applications (e.g. Excel, Outlook)
- Ability and desire to work in a team-oriented environment.
- Excellent written and verbal communication skills
- Highly proficient with Microsoft Word, PowerPoint and Excel.
- Demonstrates ability to evaluate information and data with a defined, studied process and report results in a thoughtful, organized manner
- Possesses a collaborative, results-driven style.
- Ability to work under pressure and provide quality outputs within tight timelines
Job Description Job title Medical-Regulatory Writer – Assistant Manager Reports to Director Job purpose To plan and Manage Medico-Regulatory Writing for Regulatory in compliance to applicable...
Job Overview
The Project Lead - Pharmacovigilance position at DDReg presents an exciting opportunity to elevate your career in pharmacovigilance project management. As a vital member of our Project Management team, you will be the primary contact for clients, guiding project activities, and ensuring that projects are not only delivered on time and within scope, but also uphold the highest quality standards. Embrace this chance to make a meaningful impact in the field!
Key Accountabilities:
Providing oversight and direction for all pharmacovigilance services.
Client Relations:
- Acting as the primary liaison for clients and project teams.
- Serve as the primary contact, maintaining excellent communication and relationships with clients and internal teams.
- Ensure consistently high-quality work and client satisfaction through clear communication, regular updates, and proactive problem-solving.
Project Management:
- Develop project scope and objectives based on signed agreements, ensuring alignment with client needs and regulatory requirements.
- Plan and track project activities, ensuring deadlines and interim milestones are met. Provide regular updates to clients and management on project status.
- Coordinating with the project manager and cross-functional project resources.
- Assessing workload and coordinating with resource managers for planning.
- Supporting pharmacovigilance project setup and team training.
- Representing pharmacovigilance in client and project team meetings.
- Conducting team briefing meetings to ensure project understanding and communication.
- Ensuring delivery of high-quality pharmacovigilance work within agreed timelines.
- Monitoring quality and compliance for safety deliverables.
- Leading coordination of safety or medical information-related activities.
- Training and mentoring newly hired pharmacovigilance staff.
- Performing other activities as identified and requested by pharmacovigilance management.
Qualifications:
- Experience: 3-4 years of previous Pharmacovigilance Project Management experience, preferably within a service provider or CRO environment.
- A Life Science or Biomedical background with a healthcare-related degree (e.g., pharmacology, biology, biotechnology, veterinary science).
Skillset:
- Proficiency in PV processes/regulations including but not limited to Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding
- Excellent client-management skills, with strong communication and presentation abilities.
- Proven time management, organization, and multitasking skills with a keen attention to detail.
- Advanced verbal and written English proficiency (minimum B2 level).
- Advanced knowledge of MS Office applications (Word, Excel, PowerPoint).
Job Overview The Project Lead – Pharmacovigilance position at DDReg presents an exciting opportunity to elevate your career in pharmacovigilance project management. As a vital member of our Proj...