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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 managementÂ
Desired Candidate Profile
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 Minimum 8+ years of experience in Regulatory Affairs with a primary focus in regulated markets for the US, EU, and Canada
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Well versed in ANDA filings, drafting deficiency responses and eCTD requirements
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Expertise in submissions of various dosage forms with a primary focus on OSDs and Injectables
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Hands-on experience in eCTD submissions (Compilation/ Publishing/ Drug Listing)
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Knowledge of current regulatory requirements and guidelines
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Strong verbal and written communication skills
Qualification: B.Pharma/M.Pharma
Experience: 8-12 Years
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