Executive – Regulatory Affairs & Pharmacovigilance | Pharma Jobs in Mumbai
Looking for a Regulatory Affairs job in the pharmaceutical industry? Ferring Pharmaceuticals is hiring an Executive – Regulatory Affairs & Pharmacovigilance for one of the most sought-after Pharma jobs in Mumbai. This role involves India regulatory affairs, pharmacovigilance activities, safety reporting, and regulatory submissions, making it an excellent opportunity for professionals aiming to grow in a regulatory affairs job within Mumbai’s pharma sector.
Job Details
- Job Title: Executive – Regulatory Affairs & Pharmacovigilance
- Locations: Mumbai, India
- Job Id: R0035732
About the Company
Ferring Pharmaceuticals is a research-driven, specialty biopharmaceutical group committed to helping people around the world build families and live better lives. Ferring has an international presence with more than 6,000 employees worldwide and is dedicated to the development of therapies in reproductive health, urology, gastroenterology, endocrinology, and orthopaedics.
Job Description
This Regulatory Affairs position involves handling regulatory affairs and pharmacovigilance activities for India and South Asia. The role supports safety reporting, regulatory submissions, compliance checks, labeling updates, and coordination with global teams, positioning it among the most valuable Pharma jobs in Mumbai.
Key Responsibilities
- Reporting of safety information from India & India cluster (South Asia countries) to the Global Safety
- Follow up for additional information with the reporters
- Review the safety mailbox for the reports
- Monthly Reconciliation and Compliance checks from the PV perspective
- Submission of Periodic Safety Update Reports to the regulatory authority as per regulations
- Gathering the requirements and Preparation of dossiers for submission to the Indian regulatory authority for new products, clinical trials, variations, renewals of registration certificates, etc., preparation for query responses to the authority, coordination with the global teams
- Contribute in preparation for regulatory authority meetings and expert committee meetings
- Preparation of dossiers for regulatory submissions and follow-ups for South Asian countries
- Preparation and updation of labeling materials for our products
- Promotional material review in compliance with product registrations
- Timely information for updation of Regulatory Databases
- Updation of local SOPs
- Updation/renewal of Safety Agreements for Partners, Manufacturers, Distributors
- Coordination and checks for price updates and entry of information timely into the Pricing Authority database (NPPA)
- Lifecycle maintenance, and update the commercial team promptly of major milestones
Qualifications
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Bachelor’s in Pharmacy, Life Sciences, Microbiology, Chemistry, or similar
Experience
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1+ years in India Regulatory Affairs and Pharmacovigilance functions in the Pharma or Biotech Industry
