J. B. Chemicals & Pharmaceuticals Ltd. (JBCPL), known to many as Unique Pharmaceutical Laboratories is one of India's leading global pharmaceutical companies. The company manufactures and markets a wide range of pharmaceutical formulations.
Post : Executive - Regulatory Affairs
Job Profile:-
Responsible for preparation and compilation of ANDA as per check list provided by US FDA guidelines for to obtain the necessary authorization.
Preparation of e-CTD Modules 1,2,3 and 5 as per ANDA checklist
Arranging Documents like Letter of Authorization for DMF Holders for API / Packing material cGMP Certificate required for completion of ANDA.
Maintain awareness and knowledge of current US FDA, ICH guidelines/legislation and ensures best regulatory practice all time.
Preparing Documents for Annual Report, PADER submission, CBE-0, Labeling amendments,
Hands-on experience of eCTD Softwares for compilation of ANDA.
Review, analyze and prepare/compile documents generated by R&D, Site, QA and other related departments as per current regulatory requirements.
Handling queries from Regulatory Bodies from time to time.
To review Documents/support site during FDA Audit.
Candidate Profile : B. Pharma / M. Pharma / M.Sc. / Ph.D
Additional Information:
Exp : 3-5 Years
Location : Mumbai
Industry: Pharma / Biotech / Clinical Research
Functional Area: Production, Manufacturing, Maintenance
Role Category: Drug Regulatory Affairs/Documentation
Role: Regulatory Affairs Manager
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