WE ARE HIRING – REGULATORY AFFAIRS (DOMESTIC)

Location: Andheri, Mumbai

Positions: Sr. Executive / Assistant Manager / Deputy Manager – Regulatory Affairs

Qualification: M. Pharm.

Experience: Experienced candidates preferred

Job Overview

We are looking for experienced Regulatory Affairs professionals with expertise in domestic regulatory compliance, licensing, product registration, packaging compliance, and pharmacovigilance. The ideal candidate should have a strong understanding of Indian regulatory requirements and experience coordinating with regulatory authorities and cross-functional teams.

Key Responsibilities

1. Regulatory Affairs and Licensing

- Prepare and submit registration dossiers for approvals from State FDA, DCGI and FSSAI.
- Handle regulatory applications through FDA, SUGAM, NSWS and FSSAI FoSCoS portals.
- Manage applications for new drugs, SND, Test Licenses, Dual NOC and Export NOC.
- Ensure timely renewal of drug and food licenses for head office and branch offices across India.
- Coordinate with R&D;, QC, Production, Marketing and Legal teams to obtain technical documentation.
- Respond to technical and legal queries raised by regulatory authorities.
- Maintain regulatory records and monitor updates to applicable regulatory requirements.

2.



Packaging and Label Compliance

- Review product labels, cartons, package inserts and patient information leaflets.
- Ensure packaging artwork complies with applicable statutory and regulatory requirements.
- Prepare package inserts in accordance with the New Drugs and Clinical Trials Rules, 2019, wherever applicable.

3. Pharmacovigilance and Medical Writing

- Draft and review Periodic Safety Update Reports (PSURs).
- Review Risk Management Plans and assess product risk-benefit profiles.
- Conduct scientific reviews of aggregate safety reports and Individual Case Safety Reports (ICSRs).
- Coordinate literature research and ensure the quality of medical and safety documentation.

Required Skills and Expertise

- Strong knowledge of the Drugs and Cosmetics Act and Rules.
- Familiarity with pharmaceutical, FSSAI, cosmetics, medical device and Ayurvedic regulations.
- Knowledge of relevant regulatory schedules, including Schedule M and Schedule Y, and the Recent Drugs and Clinical Trials Rules, 2019.
- Experience in domestic FDA-related activities, licensing and regulatory submissions.
- Strong documentation, communication and cross-functional coordination skills.

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