Biological E-Regulatory Affairs Specialist-Vaccines -Indian Market

Biological E Limited is hiring for Regulatory Affairs Specialist for Indian Market for Vaccines Plant.

Experience: 7 - 14 years

Location: Shamirpet, Hyderabad

Job Purpose

• Manage end-to-end India Regulatory Affairs activities for Vaccines, Antisera, and Pharmaceutical Products.
• Ensure timely submission, approval, and lifecycle management of products with CDSCO/DCGI and State Drug Control Authorities.

Key Responsibilities

• Manage preparation, review, compilation, and submission of regulatory dossiers and applications to CDSCO/DCGI.
• Handle product registrations, manufacturing/import licences, NDAs/SNDAs, and regulatory approvals.
• Manage Post-Approval Changes (Level IIV) and regulatory lifecycle activities.
• Prepare and coordinate responses to regulatory queries, deficiencies, and observations.
• Manage submissions through SUGAM, NSWS, IBKP, ODLS, ONDLS, and applicable regulatory portals.
• Manage State DCA submissions for manufacturing licences, renewals, amendments, WHO GMP certificates, and CoPP.
• Coordinate IBSC/RCGM submissions and permissions related to GMO/LMO, recombinant products, R&D, and PCT activities.
• Conduct regulatory impact assessments and define appropriate regulatory strategies for proposed changes.
• Maintain regulatory dossiers, approval databases, licences, trackers, and regulatory correspondence.
• Review labels, pack profiles, package inserts, and artworks for regulatory compliance.
• Coordinate with QA, QC, R&D, Manufacturing, Clinical, CFT, and Supply Chain for regulatory deliverables.
• Support registration samples, tenders, technical queries, and product documentation.
• Prepare regulatory status reports for management and project reviews.
• Guide team members on RA SOPs, regulatory requirements, submission portals, and filing procedures.

Qualifications

• M.Pharm / M.Sc. / M.Tech / equivalent in Pharmacy, Biotechnology, Life Sciences, Microbiology, Biochemistry, or related discipline.
• 7-14 years relevant experience in Regulatory Affairs, preferably in Vaccines/Biologics/Pharmaceuticals.
• Strong knowledge of Indian regulatory requirements, CDSCO/DCGI submissions, licensing, and post-approval lifecycle management.

Interested applicants can share the updated CV with [email removed] - Subject Line "Application for RA Indian Market"