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Assistant Manager-Regulatory Affairs

Mumbai, MH
Job Code:
  • Biotechnology & Science
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Job Details

Job DescriptionStrategic regulatory guidance and application of product registration dossiers for manufacturing and registrationof new drug products and food products at the DCGI office & FSSAI office respectively.Extensive experience of biological drug products, NCE, new drug, subsequent new drug & fixed dose combinations dossier preparation and application to the DCGI office for the clinical trials and manufacturing permission of the new drugsAssisting R&D in new product development and existing product improvements from regulatory perspectives. Art work review, license review and approval of drug products.FDA and CDSCO Notices replies for not of standard quality complaints. Follow up for the resolution of the NSQ complaints.Coordination with the medical department for drafting the medical information like prescribing information, waiver for the clinical trials, justification and therapeutic rationale for the new drugsVigilance / Awareness to the latest rules on the use of the ingredients in food products so that substitutes can be decided.Obtaining regulatory approvals / marketing authorizations for the new drug products for Nepal. Developing and maintaining product information and labelImport and registration of Bulk drug, Cosmetics and Finished formulationsReview of the Chemistry manufacturing and controls data (CMC) of the Active pharmaceutical ingredients and finished formulation for the new drug registrationDossier compilation for the Technical review meetings and Subject expert committee meetingsParticipation in meetings with the R&D and Business development for the new product identification and regulatory strategyClose review of the SEC committee, IND committee and Technical review committee meetingsCoordination with the manufacturing locations for obtaining the CMC data for the regulatory
Degree: M.Com. (Commerce) | M.Pharm. (Pharmacy) | M.Sc. (Science) | MA (Arts) | MBA/ PGDM | MCA/ PGDCA

Additional Degree: BA (Arts) | B.Com. (Commerce) | B.Pharm. (Pharmacy) | B.Plan. (Planning) | B.Sc. (Science) | BBA/ BBM/ BBS | BCA (Computer Application) | Diploma-Other Diploma | B.Ed. (Education) | BHM (Hotel Management)

Experience: 2-6


Regulatory Affairs
Applying for this job will take you to an external site


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