Biological E. Limited is hiring a Senior Executive – Regulatory Affairs (RoW – Vaccines & Biologics) at its Shamirpet location.
This Regulatory Affairs job in Shamirpet focuses on CTD/eCTD dossier preparation, lifecycle management, and RoW market submissions for vaccines and biologics. Candidates with hands-on experience in MAA, CTA, PAC handling, and authority query responses will be preferred.
If you are an eCTD Specialist for RoW markets with exposure to vaccine or biological product regulations, this is a high-growth opportunity.
🔬 Key Responsibilities – Regulatory Affairs (RoW Vaccines & Biologics)
The selected candidate for this Senior Executive Regulatory Affairs job will handle:
- Preparation and compilation of CTD/eCTD dossiers for RoW markets
- Regulatory lifecycle management for vaccines and biologics
- Handling MAAs (Marketing Authorization Applications) and CTAs (Clinical Trial Applications)
- Managing Post-Approval Changes (PACs)
- Responding to regulatory deficiency letters and health authority queries
- Review of labeling, pack inserts, pack profiles, and artworks
- Coordination with QA, QC, Manufacturing, and R&D for submission readiness
- Managing submissions through regulatory portals such as:
- SUGAM
- IBKP
- NSWS
- ONDLS
This Regulatory Affairs RoW Vaccines job demands strong understanding of global regulatory requirements for biological products.
🎓 Qualifications Required
- B.Pharm / M.Pharm / Life Sciences
- Experience in Regulatory Affairs – RoW market submissions
- Exposure to Vaccines or Biologics regulatory filings preferred
- Hands-on knowledge of eCTD submission tools
- Understanding of global guidelines for vaccines and biologics
💼 Experience Required
- Experience in Regulatory Affairs RoW markets
- Strong expertise in:
- CTD/eCTD documentation
- Regulatory lifecycle management
- Handling authority queries
- Biological product submissions
Professionals working as RA Executive – Vaccines, Regulatory Affairs eCTD Specialist, or RoW Regulatory Executive can apply.
💰 Salary (Estimated)
- ₹8,00,000 – ₹14,00,000 per annum (CTC)
(Salary may vary based on experience and expertise in vaccines & biologics submissions)
📍 Job Location
Shamirpet, Telangana
Biological E. Limited
🌟 Why Join Biological E?
- Work with a reputed vaccine and biologics manufacturer
- Exposure to global RoW regulatory markets
- Opportunity to handle high-impact biological submissions
- Career growth in specialized Regulatory Affairs Vaccines domain
📩 How to Apply?
Interested candidates can:
📧 Email updated CV to: HR.Intern4@biologicale.com