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Position: Manager – Corporate Regulatory Affairs

Location: Mumbai, Maharashtra

Job Description:

  • Compilation and submission of Abbreviated New Drug Applications (ANDAs) in CTD format for the US and other markets as per respective regulatory requirements
  • Compilation of responses pertaining to CMC, Dissolution, Bioequivalence, Microbiology and Labeling deficiencies and ensuring that registration approvals are granted without undue delay
  • Labeling, SPL and drug listing activities
  • Review and approval of submission related documents such as Batch Manufacturing Records, Packaging Records, Analytical Reports, Stability reports, Technology transfer documents

  • Drafting controlled correspondences to USFDA
  • Due diligence of products planned for acquisition
  • Knowledge-sharing with stakeholders like Plant, R&D on the latest requirements of regulatory bodies aiming to achieve quality filings and product approval within the defined timelines (e.g. ANDA GDUFA goal dates)
  • Identifying the appropriate filing category for post-approval changes and submissions to USFDA
  • Preparation of regulatory strategy documents
  • Providing regulatory costing for new projects
  • Participation in site audit/inspection, when scheduled
  • Lifecycle management of approved products
  • Database management 

Desired Candidate Profile

  •  Minimum 8+ years of experience in Regulatory Affairs with a primary focus in regulated markets for the US, EU, and Canada

  • Well versed in ANDA filings, drafting deficiency responses and eCTD requirements

  • Expertise in submissions of various dosage forms with a primary focus on OSDs and Injectables

  • Hands-on experience in eCTD submissions (Compilation/ Publishing/ Drug Listing)

  • Knowledge of current regulatory requirements and guidelines

  • Strong verbal and written communication skills

Qualification: B.Pharma/M.Pharma

Experience: 8-12 Years

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