Job Description - Manager Regulatory

AffairsDepartment : Regulatory Affairs Reporting To : Head Medical Services Location :Mumbai Industry : Pharmaceutical / Animal Health / Healthcare

Job Summary The 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

- Coordinate with State FDA, CDSCO, and other regulatory authorities for obtaining approvals, licenses and license renewals

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.
- Knowledge of labeling and artwork compliance requirements
- Familiarity with regulatory portals and electronic submission systems
- Solid 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 :

- Master's (preferred)

Work Location: In person

📌 Manager - Regulatory Affairs (Mumbai)
🏢 Samarth Life Sciences
📍 Mumbai