Career Openings
Job Purpose:
We are seeking a detail-oriented and proactive Regulatory Affairs Specialist to support global regulatory submissions and lifecycle management for pharmaceutical products. The ideal candidate will have hands-on experience with CTD/eCTD documentation, regulatory compliance, and dossier preparation, particularly for Canada Markets.
Key Responsibilities:
- Regulatory Compliance:
In-depth knowledge of Health Canada regulations, guidance documents, and submission formats. and will be responsible for preparing and submitting regulatory documentation for ANDS, maintaining compliance records, and liaising with regulatory agencies. - eCTD/CTD Sequence Review:
Maintain up-to-date knowledge of eCTD requirements and review of the sequence to ensure submission quality and compliance with regulatory standards. - Query Handling & Documentation:
Draft and review regulatory authority responses. Ensure clarity, regulatory alignment, and timely submission. - Functional File Preparation:
Handle electronic publishing tasks including hyperlinking, bookmarking, redactions, and formatting. Ensure technical accuracy and reduce rework. - Artwork & Labeling Review:
Prepare label texts and review of artworks. Ensure accuracy, consistency, and regulatory compliance. - Project Tracking & Documentation:
Maintain trackers, task planners, product history logs, and query records. Participate in client meetings and contribute to regulatory planning. - Team Collaboration & Communication:
Collaborate with internal stakeholders and external clients. Ensure timely follow-ups, documentation clarity, and professional engagement.
Educational Qualifications:
B Pharm/ M Pharm
Soft Skills:
- Strong communication and interpersonal skills
- Time management and multitasking
- Analytical thinking and collaboration
- Positive, adaptable attitude
Job Features
Job Purpose: We are seeking a detail-oriented and proactive Regulatory Affairs Specialist to support global regulatory submissions and lifecycle management for pharmaceutical products. The ideal candi...
Job Purpose:
We are seeking a detail-oriented and proactive Regulatory Affairs Specialist to support global regulatory submissions and lifecycle management for pharmaceutical products. The ideal candidate will have hands-on experience with CTD/eCTD documentation, regulatory compliance, and dossier preparation, particularly for US Markets.
Key Responsibilities:
- Regulatory Compliance:
Strong understanding of U.S. regulatory requirements, particularly FDA guidelines, and will be responsible for preparing and submitting regulatory documentation for ANDA, maintaining compliance records, and liaising with regulatory agencies. Knowledge about post approval activities is an added advantage. - eCTD/CTD Sequence Review:
Maintain up-to-date knowledge of eCTD requirements and review of the sequence to ensure submission quality and compliance with regulatory standards. - Query Handling & Documentation:
Draft and review regulatory authority responses. Ensure clarity, regulatory alignment, and timely submission. - Functional File Preparation:
Handle electronic publishing tasks including hyperlinking, bookmarking, redactions, and formatting. Ensure technical accuracy and reduce rework. - Artwork & Labeling Review:
Prepare and review artworks and comparative labeling texts. Ensure accuracy, consistency, and regulatory compliance. - Project Tracking & Documentation:
Maintain trackers, task planners, product history logs, and query records. Participate in client meetings and contribute to regulatory planning and decision-making. - Team Collaboration & Communication:
Collaborate with internal stakeholders and external clients. Ensure timely follow-ups, documentation clarity, and professional engagement.
Educational Qualifications:
B Pharm/ M Pharm
Soft Skills:
- Strong communication and interpersonal skills
- Time management and multitasking
- Analytical thinking and collaboration
- Positive, adaptable attitude
Job Features
Job Purpose: We are seeking a detail-oriented and proactive Regulatory Affairs Specialist to support global regulatory submissions and lifecycle management for pharmaceutical products. The ideal candi...
Full Stack Developer (MERN Stack)
Job Title: Sr. SDE -Full Stack Developer (MERN Stack)
Experience Required: 4+ Years
Location: Gurgaon (Onsite)
About the Role:
We are seeking an experienced Full Stack Developer with a strong command of the MERN stack (MongoDB, Express.js, React.js, Node.js) to join our engineering team. The ideal candidate should have hands-on experience in building scalable web applications, with additional proficiency in TypeScript and Next.js.
Key Responsibilities:
- Design, develop, and maintain high-quality, scalable applications using the MERN stack.
- Write clean, efficient, and modular code following best development practices.
- Implement frontend applications using React.js and Next.js with TypeScript.
- Build responsive and optimized UI components; familiarity with Tailwind CSS is preferred.
- Collaborate on system design and database architecture (SQL & NoSQL).
- Work with Python-based scripts or services for automation or backend integrations.
- Configure and manage CI/CD pipelines to streamline deployment workflows.
- Set up, deploy, and maintain applications on Ubuntu servers, including Nginx configuration and optimization.
- Utilize AWS services (EC2, S3, RDS, etc.) for application hosting and scalability.
- Participate in code reviews, provide technical mentorship, and contribute to architectural decisions.
Required Skills & Qualifications:
- Bachelor’s degree in Computer Science, Engineering, or a related field (or equivalent experience).
- 4+ years of professional experience as a Full Stack Developer.
- Strong expertise in MERN stack (MongoDB, Express.js, React.js, Node.js).
- Proficiency in TypeScript and experience with Next.js.
- Familiarity with Tailwind CSS or other modern UI frameworks.
- Understanding of system and database design principles.
- Experience with CI/CD setup, Git-based version control, and automated deployment workflows.
- Knowledge of Ubuntu/Linux server management and Nginx configuration.
- Exposure to AWS infrastructure for deployment and scalability.
- Excellent problem-solving, debugging, and analytical skills.
Preferred (Nice-to-Have):
- Working knowledge of Python for backend scripting or automation.
- Experience with Docker or Kubernetes for containerized deployments.
- Familiarity with monitoring tools (Grafana, Prometheus, ELK).
- Prior experience mentoring junior developers or leading small teams.
Why Join Us:
- Opportunity to work on modern, scalable, full-stack applications.
- Exposure to advanced web technologies and cloud infrastructure.
- Collaborative, fast-paced, and innovation-driven culture.
- Competitive compensation and career growth opportunities.
Job Features
Job Title: Sr. SDE -Full Stack Developer (MERN Stack) Experience Required: 4+ Years Location: Gurgaon (Onsite) About the Role: We are seeking an experienced Full Stack Developer with a strong comman...
Associate- Regulatory Affairs- India Market
Job Purpose:
DDReg is seeking a qualified Regulatory Affairs Specialist to join our team, responsible for ensuring compliance with regulatory requirements for India for a portfolio comprising of New Drugs, Generics, Biologicals, Cosmetics, Medical Devices & Nutraceuticals.
Key Responsibilities:
As a Regulatory Affairs Specialist for India the key responsibilities will include:
- Managing CDSCO regulatory submissions for:
• New Drugs – both Synthetic and Biologicals
• Generics and Biosimilars
• medical devices
• Nutraceuticals
• Cosmetics. - Preparing and reviewing dossiers for registration and import licenses.
- Ensuring compliance with pharmaceutical regulations
- Handling regulatory intelligence and change management processes.
- Managing product lifecycle activities, including amendments and renewals.
- Utilizing the Sugam Portal for regulatory submissions and approvals.
- Obtaining and maintaining various licenses such as CT-06/07/11/13/14/15/ 17/ 19/ 20/ 22/ 23/ 24// 25/ 27; COS-2/4/, MD-15/5/9, Form 41 etc
- Submitting applications for new drug, medical device, and diagnostic kit registrations.
- Liaising with CDSCO/DCGI for application follow-ups and deficiency letter resolutions.
- Proficiency in handling SUGAM Portal
- Submitting applications and obtaining permissions and licenses from FSSAI, Legal Metrology for Nutraceutical products
- Sound understanding of guidelines regarding import of New Drugs, Medical Devices, Diagnostics into India.
- Query replied for the deficiency letters obtained from CDSCO/DCGI.
- Having good track record on obtaining certificates for registration, import license, test license, manufacturing license etc.
Educational Qualifications:
- Bachelor's or master's degree in pharmacy, Life Sciences, or a related field.
- Minimum 3+ years of experience in regulatory affairs within the drugs, cosmetics, Nutraceuticals & Medical Devices industry, with a focus on CDSCO regulations and utilizing the Sugam Portal.
- Sound knowledge of CDSCO regulations and guidelines pertaining to Drugs/Cosmetics/Medical Devices especially related to the Sugam Portal.
- Familiarity with the registration process for drugs/ nutraceuticals/ Cosmetics/Medical Devices in India, including dossier preparation and submission requirements via the Sugam Portal.
- Strong understanding of quality management systems and Good Manufacturing Practices (GMP) in the drugs, Cosmetics/Medical Devices industry.
- Excellent attention to detail and ability to interpret complex regulatory information.
- Effective communication and interpersonal skills to collaborate with internal and external stakeholders.
- Proactive problem-solving abilities and ability to work independently with minimal supervision.
- Ability to prioritize tasks, meet deadlines, and adapt to changing regulatory requirements.
Soft Skills:
- Strong communication and interpersonal skills
- Time management and multitasking
- Analytical thinking and collaboration
- Positive, adaptable attitude
Job Features
Job Purpose: DDReg is seeking a qualified Regulatory Affairs Specialist to join our team, responsible for ensuring compliance with regulatory requirements for India for a portfolio comprising of New D...
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 Features
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...
Sr. Manager-Regulatory Affairs- US/EU
Experience: -15+ Years
Location: Gurgaon
We are looking for an experienced and accomplished Senior Manager – Regulatory Affairs (CMC) with deep expertise in US and EU regulatory frameworks. The role will drive regulatory strategy, dossier submissions, and lifecycle management activities across these key markets, ensuring compliance and regulatory excellence. The ideal candidate will bring 15+ years of proven experience in regulatory affairs, with a strong command of CMC regulations and a successful track record of managing complex global submissions.
Roles & Responsibilities
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Lead CMC review of technical documentation for regulatory filings in US and EU markets, including Gap Analysis and Remediation for Module 3 (CMC).
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Develop and implement regulatory strategies, processes, and timelines for new product registrations, variations, renewals, and post-approval changes in the US and EU.
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Oversee the preparation, review, and submission of CTD dossiers, ensuring conformance with FDA, EMA, and ICH guidelines.
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Critically evaluate submission documentation for scientific accuracy, compliance, and internal consistency.
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Provide regulatory intelligence by tracking changes in US and EU regulations, guidelines, and best practices.
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Collaborate closely with cross-functional teams (R&D, QA, Manufacturing, and Commercial) to ensure regulatory strategies are aligned with business objectives.
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Represent the company in discussions with regulatory authorities (FDA, EMA, and other relevant agencies).
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Mentor and guide junior regulatory team members, fostering a culture of regulatory excellence.
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Education & Experience
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Master’s degree in Pharmacy (Pharma) or a related field.
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15+ years of regulatory affairs experience, with significant exposure to US and EU CMC submissions.
Knowledge, Skills & Abilities
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In-depth knowledge of US FDA, EMA, and ICH CMC guidelines.
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Strong ability to interpret and analyze complex technical and scientific data.
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Exceptional oral and written communication skills, with strong presentation abilities.
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Proven leadership and mentoring skills with a collaborative, results-driven style.
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Excellent problem-solving and decision-making capabilities.
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Proficiency with document management systems and Microsoft Office Suite (Word, PowerPoint, Excel, Outlook).
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Ability to manage multiple priorities and deliver high-quality outputs under pressure.
Why Join Us?
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Play a key leadership role in shaping regulatory strategies for high-priority US and EU markets.
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Opportunity to lead impactful submissions and contribute to global product approvals.
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Exposure to cross-functional teams and business strategies.
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Work in a collaborative environment with a focus on innovation and regulatory excellence.
Job Features
Sr. Manager-Regulatory Affairs- US/EU Experience: -15+ YearsLocation: Gurgaon We are looking for an experienced and accomplished Senior Manager – Regulatory Affairs (CMC) with deep expertise in US ...
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 Features
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...
Project Manager – Regulatory Affairs
Job Summary:
We are seeking an experienced and highly motivated Project Manager (Regulatory Affairs) to lead and manage regulatory projects from initiation to completion, ensuring timely and successful product registration, market authorization, and compliance with relevant regulatory requirements. The ideal candidate will have a deep understanding of global regulatory frameworks, exceptional project management skills, and experience working with cross-functional teams to deliver regulatory affairs services in the pharmaceutical industry.
As a Project Manager, you will be responsible for overseeing the full lifecycle of regulatory projects, ensuring alignment with market standards, timelines, and quality requirements. This role requires strong leadership, strategic thinking, and the ability to collaborate with various internal and external stakeholders to drive the successful delivery of regulatory affairs objectives.
Key Responsibilities:
- Project Management:
Lead and manage regulatory projects (e.g., drug registrations, labeling updates, product lifecycle management) in accordance with regulatory requirements.
Develop and maintain detailed project plans, including timelines, budgets, and resource allocation, to ensure successful project delivery.
Coordinate with internal teams (Regulatory Affairs, Clinical, CMC, QA, etc.) and external stakeholders (regulatory authorities, vendors, partners) to ensure regulatory submissions are prepared accurately and on time.
Monitor project progress, identify risks, and implement corrective actions to resolve any potential issues.
Ensure all regulatory activities are executed in compliance with local, regional, and global regulations and guidelines. - Regulatory Strategy & Compliance:
Provide guidance on regulatory strategy for new product development, life-cycle management, and post-market compliance.
Support the regulatory submission process by ensuring all required documents, data, and information are prepared, submitted, and tracked according to regulatory authority requirements.
Maintain an up-to-date understanding of global regulatory changes (FDA, EMA, ICH, etc.) and their impact on the organization’s products and projects. - Cross-functional Collaboration:
Work closely with R&D, quality assurance, manufacturing, and other departments to ensure regulatory considerations are incorporated throughout the product development lifecycle.
Foster strong relationships with regulatory agencies and external partners to influence and expedite approval processes. - Documentation & Reporting:
Ensure that regulatory submissions, dossiers, and project documentation are organized, complete, and compliant with regulatory guidelines.
Prepare and present regular project updates and reports to senior management and key stakeholders on project status, timelines, risks, and issues. - Continuous Improvement:
Identify areas for improvement in regulatory processes and propose solutions to increase efficiency and compliance.
Drive regulatory best practices and ensure adherence to internal SOPs, industry standards, and regulatory requirements.
Qualifications:
- Bachelor’s or master’s degree in Life Sciences, Pharmacy, Regulatory Affairs, or a related field.
- Certification in Regulatory Affairs (e.g., RAC) preferred.
Experience:
- Minimum of 5-7 years of experience in Regulatory Affairs, with at least 3-5 years in project management in the pharmaceutical industry (CRO, Biopharma, or consulting firm experience preferred).
- Proven experience managing regulatory submissions (e.g., IND, NDA, MAA, etc.) in various regions.
- Strong understanding of global regulatory requirements, guidelines (FDA, EMA, ICH, etc.), and pharmaceutical industry standards.
- Demonstrated expertise in managing cross-functional teams, timelines, budgets, and project deliverables.
Skills:
- Strong project management skills, including proficiency in project management tools (e.g., MS Project, Jira, etc.).
- Excellent written and verbal communication skills, with the ability to effectively interact with senior stakeholders and regulatory authorities.
- Detail-oriented with strong organizational skills and the ability to manage multiple projects simultaneously.
- Ability to navigate complex regulatory environments and provide clear regulatory guidance.
- Strong problem-solving skills, with the ability to assess risks and implement mitigation strategies.
Personal Attributes:
- Leadership and team-oriented mindset.
- Strong analytical thinking and attention to detail.
- Ability to thrive in a fast-paced, dynamic environment.
- High level of integrity and ethical standards.
- Proactive and solution-oriented approach to problem-solving.
Job Features
Job Summary: We are seeking an experienced and highly motivated Project Manager (Regulatory Affairs) to lead and manage regulatory projects from initiation to completion, ensuring timely and successfu...