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.
Post : Regulatory Affairs - Biologics / Vaccines - Indian Market
Job Responsibilities :
• Responsible for Preparation of Regulatory Documents for submission to Indian Regulatory Authorities.
• Experienced in handling, management and expansion of product portfolios, markets/ territories.
• Experienced in the preparation, review and submission of applications/ response to RCGM vide IBSC.
• Expertise in preparation, compilation and submission of Indian NRA applications (Eg: Form CT 10, 16, CT18, 40, 10, Export NoC, etc., but not limited)
• Well versed with Indian NRA submission portals, IBKP, SUGAM, NSWS, ODLS/ ONDLS, etc.
• Author, review and compilation of Regulatory Packages like Briefing documents, Scientific package, Pre-IND packages, Clinical Trial, Expedited request, Pre-qualifications, etc.
• Author, review, compile and submission of Marketing Authorization Applications (CTD/ ACTD/ eCTD) in India, Emerging Markets, Regulated Markets and Vaccine Prequalification Dossier to WHO.
• Application for Post Approval Change(s), Variations and Comparability packages
• Author, review and submission of responses to India, EM, WHO and Regulated markets..
• Hands-on experience with MS office tools, PDF, Track Wise, DMS, Veeva Vault, Lorenz/ Pharma ready, etc..
• Handling the Health Agency audits for India, EM, Regulated and WHO inspections
• Coordination with cross functional departments like QA, QC, Production, Warehouse, Distribution, Marketing and various teams (Internal & External).
• Review of Artworks (Labels and Package Insert) and Pack Profiles.
• Any other regulatory support required by the organization per submission need.
Additional Information
Experience : 5- 11 years
Job Location : Genome Valley, Shameerpet, Hyderabad
Preferred Industry : Vaccines / Biotech
Designation : Senior Executive/ Assistant Manager
Qualification : M.Pharma / M.Sc / B.Pharma
Interested Candidates having relevant experience can send in their CVs to HR.Intern4@biologicale.com by mention the subject as Applying for "Regulatory Affairs"
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