Job Description – Manager Regulatory
AffairsDepartment: Regulatory Affairs
Reporting To: Head Medical Services
Location: Mumbai
Industry: Pharmaceutical / Animal Health / Healthcare
Job SummaryThe Regulatory Affairs Manager is responsible for obtaining and maintaining regulatory approvals, licenses, registrations, and statutory compliance for pharmaceutical products. The role involves preparation and submission of regulatory dossiers, coordination with regulatory authorities, preparation, review and approval of product artworks, support for product registrations, import/export regulatory activities, and cross-functional collaboration with manufacturing, R&D, business, and distribution teams.
Key Responsibilities
Regulatory Licensing & Approvals
- Prepare and submit applications for Product Permissions, Loan Licenses, Wholesale Licenses, and other statutory approvals
- Coordinate with State FDA, CDSCO, and other regulatory authorities for obtaining approvals, licenses and license renewals
- Track application status and ensure timely closure of regulatory queries
Regulatory Submissions & Documentation
- Prepare, compile, review, and maintain regulatory dossiers and supporting documents for submissions
- Prepare documentation for FDA submissions and regulatory inspections
- Maintain regulatory records, approvals, licenses, and correspondence
Artwork Review & Label Compliance
- Review and approve product artworks for in-house manufacturing, third-party manufacturing, and tender business
- Ensure compliance of labels, cartons, inserts, and packaging materials with applicable regulatory requirements
- Prepare and verify product content, claims, prescribing information, and statutory declarations
Portal Management & Regulatory Databases
- Update and maintain regulatory information on CDMS and other government portals
- Support registrations and renewals through various regulatory portals, including ONDLS and other applicable platforms
- Ensure timely submission and updating of regulatory information.
Regulatory Coordination
- Coordinate with Manufacturing, Quality Assurance, Quality Control, R&D, Supply Chain, and Business teams for regulatory compliance
- Liaise with CDSCO officials, State FDA authorities, and external consultants as required
- Provide regulatory support to liaisoning teams for product approvals and registrations
Qualifications
- B. Pharm / M. Pharm / B.Sc. / M.Sc. in Life Sciences or related discipline
- 2–5 years of experience in Regulatory Affairs within pharmaceutical, veterinary, or healthcare industries
Required Skills
- Strong knowledge of CDSCO and State FDA regulations.
- Experience with Loan License, GMP, Product Permission, and Wholesale License applications
- Knowledge of labeling and artwork compliance requirements
- Familiarity with regulatory portals and electronic submission systems
- Strong documentation, communication, and coordination skills
- Ability to work effectively with regulatory authorities and cross-functional teams
Preferred Knowledge
- Drugs & Cosmetics Act and Rules
- CDSCO regulatory processes
- FSSAI regulations
Pay: ₹450,000.00 - ₹800,000.00 per year
Benefits:
- Flexible schedule
- Provident Fund
Education:
Work Location: In person
