Job Description:

We are looking for an experienced Manager Regulatory Affairs (LATAM) to lead regulatory submissions, product registrations, and compliance activities across Latin American markets. The ideal candidate should have robust experience in international regulatory affairs, CTD/ACTD dossier preparation, and handling regulatory requirements for global markets.
Manage regulatory activities for new product registrations and lifecycle management across LATAM markets.
Coordinate with internal teams, overseas partners, and regulatory consultants for ongoing and recent product submissions.
Prepare, review, and compile CTD/ACTD regulatory dossiers as per country-specific guidelines.
Ensure timely submission of registration dossiers, technical documents, tender documents, LOAs, and regulatory correspondence.
Manage product registrations, renewals, variations, and regulatory maintenance activities.




Prepare and coordinate regulatory documents including Manufacturing Licenses, Product Permissions, Free Sale Certificates, CPP/COPP, and other regulatory certificates.
Liaise with regulatory authorities and agencies for manufacturing licenses, export licenses, and registration approvals.
Handle regulatory queries, deficiency responses, and communication with regulatory authorities/partners.
Lead and mentor the Regulatory Affairs team and ensure timely completion of assigned activities.

Desired Candidate Profile:
M.Pharm / B.Pharm / Pharmaceutical Sciences or equivalent qualification.
11 to 16 years of experience in Regulatory Affairs with exposure.
Robust leadership and communication skills.

Job Location : Mumbai

📌 Regulatory Affairs Manager Mumbai Suburban (India)
🏢 Ciron Drugs & Pharmaceuticals
📍 India