Job Description

Submission of Regulatory dossiers for targeted markets as per business needs to support CDMO and Agile businesses Key Stakeholders: Internal Sites - Pithampur, Lexington, Morpeth, PPDS-Ahmedabad, Mumbai RD, Digwal, Supply Chain, Finance, Shared Services, Patent, CQA Key Stakeholders: External NorthStar, Generic Partners, Towa, Breckenridge, Slate Run, Other Clients as finalized Experience Minimum 8+ years of experience in Regulatory Affairs with primary focus in regulated markets for US, EU and Canada. Experience in ROW market would be an added advantage. Responsibility Compilation and submission of Abbreviated New Drug Applications (ANDAs) in CTD format for 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, RD on latest requirements of regulatory bodies aiming to achieve quality filings and product approval within the defined timelines (eg 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 Data base management Competencies Well versed in ANDA filings, drafting deficiency responses and eCTD requirements Expertise in submissions of various dosage forms with 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 Masters in Science (M.Sc.) or Pharmacy (M.Pharm.)

foundit