Hiring Alert: Regulatory Affairs (Domestic) - Sr. Executive / Asst. Manager / Deputy Manager

Location: Andheri, Mumbai

Qualification: M. Pharm (Experience preferred)

We are currently looking for an experienced professional to join our team as a Sr. Executive / Asst. Manager / Deputy Manager - Regulatory Affairs (Domestic) based in Andheri, Mumbai.

This role involves driving local regulatory functions, licensing, statutory compliance, and pharmacovigilance activities.

Key Responsibilities:

Local Regulatory Function & Licensing:

- Prepare registration dossiers to secure certificates and licenses from local FDA, DCGI, and FSSAI.
- Utilize online portals proficiently, including FDA, Sugam, NSWS, and FSSAI (FOSCOS), with a strong understanding of the Drugs & Cosmetics Act, Schedules (Sch Y, M, NDCT 2019, etc.).
- Confirm product formula and label acceptability and ensure licenses are secured prior to product release.
- Coordinate with QC and R&D; departments for technical documents (batch records, specifications, analytical methods, validation reports, stability data) for dossiers.
- Ensure timely renewal of drug and food licenses for the head office and branch offices nationwide.
- Handle online applications for recent drugs, SND, Test Licenses, Dual NOC, and Export NOC,



while maintaining archival records of all regulatory permissions.
- Monitor regulatory updates and prepare responses to legal and technical queries raised by authorities.

Compliance of Packaging Modules:

- Formulate and implement statutory requirements for product artworks (labels, cartons, package inserts, PILs).
- Review packaging material artworks and draft package inserts as per New Drugs and Clinical Trials Rules (NDCT) 2019.

Pharmacovigilance:

- Drive high-quality medical writing through planning and coordination of literature research.
- Draft and review PSURs focusing on medical aspects and product safety sections, along with Risk Management Plans.
- Assess the risk-benefit profile of products, identify gaps in aggregate documents, and conduct scientific reviews of aggregate reports/ICSRs produced by PV associates.

How to Apply:

Interested candidates with relevant expertise in the D&C; Act, FSSAI, cosmetics, medical devices, or ayurvedic regulations can send their updated resume directly to [email protected] or drop a message to connect. Candidates attending interviews are requested to carry a photograph.

📌 Regulatory Affairs Domestic (Mumbai)
🏢 CliniLaunch Research Institute
📍 Mumbai