Are you an experienced Regulatory Affairs professional in the Pharma/Biotech industry? Biological E. Limited is hiring for multiple roles in Hyderabad. Apply today!
About Biological E. Limited
Biological E. Limited (BE) is a pioneer in India’s pharmaceutical and biotech industry, established in 1953. As the first private-sector biological products company in India, BE has been a leading supplier of Heparin and Noscapine-based cough medications. With a strong presence in vaccines and biotech, BE continues to innovate and expand globally.
Job Opening: Regulatory Affairs Professionals
Location: Genome Valley, Shameerpet, Hyderabad
Experience: 3-7 years
Designation: Deputy Manager / Assistant Manager / Senior Executive / Executive
Qualification: M.Pharmacy / M.Sc / B.Pharmacy
Industry Preference: Vaccines / Biotech
Job Description
The selected candidate will be responsible for preparing and submitting regulatory documents to Indian NRA, WHO, and other global authorities.
Key Responsibilities:
✔ Preparation of Regulatory Submission Packages (Marketing Authorization, Clinical Trials, Post-Approval Changes)
✔ Handling SUGAM, IBKP, NSWS & ONDLS/ODLS submissions
✔ Responding to Regulatory Authority queries
✔ Dossier preparation for Indian & ROW (Rest of World) submissions
✔ Coordination with QA, QC, Production, and Marketing teams
✔ Review of Pack Profiles, Artworks, Labels, and Package Inserts
✔ Managing documentation databases and regulatory compliance
How to Apply?
Interested candidates with relevant experience can send their CVs to HR.Intern4@biologicale.com with the subject line:
“Applying for Regulatory Affairs Department”
🔗 Join a legacy of excellence at Biological E. Limited!
