Job Archives
Posted 4 days ago
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 ...
Posted 2 weeks ago
Job Purpose
At DDReg Pharma, people are our most vital resource. We’re on the lookout for skilled HR recruiters who will help us find the person for a job. The ideal HR recruiter candidate will have experience in HR recruitment and is skilled in screening, talent acquisition, interviewing and employee onboarding. We are in the pursuit of finding someone ready to discover untapped talent, handle the overall organisational growth and enable people to develop successful careers.
Objectives of the role
- Work closely with HR manager or senior management to better understand the hiring needs of the company across various verticals and roles.
- Manage the full recruiting lifecycle, as a talent acquisition specialist, HR head-hunter and HR recruiter
- Foster and build relationships with potential candidates and effectively use the database to fill in existing roles
- Coordinate and partner with the talent acquisition team to design and execute recruitment strategies.
Responsibilities
- Design and implement job descriptions as per the guidance of HR manager or Senior management.
- Write and post job descriptions, and frequently engage with prospective candidates on various hiring and social media portals
- Screen incoming resumes from potential candidates and maintain the application forms and database through the entire span of the hiring process
- Identify future hiring needs and collaborate with HR managers or senior management to work toward the same
Required skills and qualifications
- Bachelor’s degree in Pharma or previous work experience as an HR recruiter or a similar role in HR talent acquisition in pharma industry
- 2+ years' experience in HR recruiter hiring and developing recruitment strategies
- Outstanding oral, written and interpersonal communications skills
- Knowledge of productivity software, database management and internet search methods
- Experience working with computer systems for HR and navigating job boards
Job Purpose At DDReg Pharma, people are our most vital resource. We’re on the lookout for skilled HR recruiters who will help us find the person for a job. The ideal HR recruiter candidate will have...
Posted 2 weeks ago
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...
Posted 2 weeks ago
Job Descriptions
- CMC review of technical documentation for regulatory filings to various markets – market: EU & UK- Gap Analysis and Remediation for module 3 -CMC
- Development and implementation of regulatory strategies, processes and timelines for grant of MAs.
- Prepare and compile 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.
- 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
- 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- Gap Analysis and Remediation for module 3 -CMC Development and implementation ...
Posted 2 weeks ago
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...
Posted 2 weeks ago
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...
Posted 2 weeks ago
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 ...
Full Time
Gurgaon
Posted 3 weeks ago
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...
Full Time
Gurgaon
Posted 3 weeks ago
Job Description
Job purpose
To plan and Manage Medico-Regulatory Writing for Regulatory in compliance to applicable Regulatory Guidelines
Duties and responsibilities
| 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...
Full Time
Gurgaon
Posted 4 weeks ago
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...
Posted 3 months ago
Seeking candidature of candidates with minimum 10 years of experience in Corporate Quality Assurance (CQA). CQA candidates from CROs preferred.
Roles & Responsibilities
- Implement systems that allow DDReg to meet its commitment to quality and add value for the customers.
- Continuous review of working levels processes to ensure compliance wrt the working level SOPs set within the Company.
- Constant upgrade of the Standard Operating Procedures as per applicable guidelines.
- Single Point of Contact for audits by client and for inspections by Health Authorities.
- Participate in Audits/inspections to ensure quality, integrity, and compliance with respect to ISO and regulatory requirements.
- Identify training needs of the working level teams from a compliance perspective.
- Identify and assess potential risks to quality, business continuity plan and work with senior leadership to develop mitigation strategies.
- Participate in risk management activities across projects and processes.
- define quality standards for each function within the organization.
- stay updated with global corporate quality Assurance standards.
- Monitoring and reporting on the quality of systems compliances.
- Quality check
- Reasoning and scientific skills
- Assessment skills
- Analytical and persuasion
- Good communication
- Collaborative working
Seeking candidature of candidates with minimum 10 years of experience in Corporate Quality Assurance (CQA). CQA candidates from CROs preferred. Roles & Responsibilities Implement systems that allo...
Full Time
Gurgaon
Posted 7 months ago
Job Description
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
| Job title | AGM/Senior Manager |
| Reports to | Director |
- 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
- 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.
- 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
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...
Full Time
Gurgaon
Posted 8 months ago
Job Description
Responsibilities:
| Job title | Software Development Team Lead |
| Reports to | Director |
- Works closely with the Product Leads to have a solid understanding of business and product.
- Is accountable for the applications the Dev teams develop and assists with questions and PROD support when needed;
- Capable of understanding and contributing to the technical solution from design through to code level
- Able to analyze and evaluate technical risks within the scope of a project and make judicious recommendations;
- Define delivery phases of the project including activities, sub-activities, and milestones ensuring these are documented and used as the basis for the project event log, issues and risk log and any subsequent reporting
- Ensure awareness, involvement and support from the key stakeholders and participants by building strong project teams and maintaining robust communication on the project status throughout its life
- Works with Training department to communicate changes to internal and external users;
- Responsible for delivering projects on budget, on time, to requirements, and with high quality;
- Managing the delivery of multiple complex simultaneous system development projects from design through to release
- Should be competent presenting technical information to a range of audiences including non-technical audiences;
- Leads a team working on significant and critical projects. Provides both technical and team leadership and mentoring;
- Responsible for performance evaluations of team members and assisting in the compensation process;
- Comfortable with documentation and creating infrastructure diagrams;
- Comfortable communicating directly with clients;
- Git, Source Tree;
- Worked in an Agile environment;
- Healthcare IT experience;
- Understanding of SOA development;
- Ability to write quality unit tests;
- Possess strong understanding of traditional RDBMS and distributed computing;
- Development on Linux;
- Experience/Knowledge with Spark and Scala;
- Experience in Spring, Hibernate, REST, ORM, JPA;
- Experience with AGILE software development methodology;
- Understanding of repeatable automated processes for building the application, testing it, documenting it, and deploying it at scale;
- Experience/Knowledge in web and backend design and development;
- Experience/Knowledge in UI frameworks and libraries like jQuery, ReactJS, Play, or AngularJS.
- Bachelors degree in Computer or Information Science-related field required; Masters degree preferred.
- At least three years of related experience required.
Job Description Job title Software Development Team Lead Reports to Director Responsibilities: Works closely with the Product Leads to have a solid understanding of business and product. Is accountabl...