Established during the Swadeshi Movement of India, Biological E. Limited (BE) started during a time when the nation sought access to critical healthcare products. Founded and led by Dr. DVK Raju, Biological E. Limited commenced its operations in 1953 as a biological products company manufacturing liver extracts and anti-coagulants. With an objective of transitioning from treating diseases to preventing them, Biological E. Limited launched its Biotechnology Division (now Vaccines and Biologics Division) and commenced large-scale production of DPT vaccines as early as 1962.
Looking for Regulatory Affairs professionals with strong experience in ROW market submissions for Vaccines & Biologics.
Post : Regulatory Affairs - Vaccines/Biologics - RoW - CTD/eCTD Specialist
Key Focus Areas :
• CTD/eCTD dossier preparation & lifecycle management for ROW markets
• Handling MAAs, CTAs & Post-Approval Changes (PACs)
• Experience with regulatory requirements specific to vaccines/biological products
• Responding to deficiency letters & authority queries
• Review of labeling, pack profiles & artworks
• Coordination with cross-functional teams for submission readiness
• Handling regulatory portals (SUGAM, IBKP, NSWS, ONDLS)
Additional Information
Qualification : B.Pharm / M.Pharm (Life Sciences)
Experience : Regulatory Affairs – ROW (Vaccines/Biologics preferred)
Location : Shamirpet, Hyderabad
Functional Area : Regulatory Affairs
End Date : 15th March 2026
Looking for candidate who can join with us within 60 days
Interested candidates may share the updated CV with HR.Intern4@biologicale.com
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