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- Sites: Pithampur, Lexington, Morpeth, PPDS-Ahmedabad, Mumbai R&D, Digwal, Supply Chain, Finance, Shared Services, Patent, CQA
- External Partners: NorthStar, Generic Partners, Towa, Breckenridge, Slate Run, Other Clients as finalized
- 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, R&D on latest requirements of regulatory bodies aiming to achieve quality filings and product approval within defined timelines (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
- 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)
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Manager - Corporate Regulatory Affairs - Mumbai - Piramal Group
1 week ago

Description
Piramal Pharma Solutions
Corporate Regulatory Affairs Department
Job Overview
We are seeking a skilled Regulatory Affairs professional to support our CDMO and Agile businesses.
Key Stakeholders:
Reporting Structure
The successful candidate will report directly to the Associate General Manager.
Experience
A minimum of + years of experience in Regulatory Affairs with primary focus in regulated markets for US, EU, and Canada is required. Experience in ROW market is an added advantage.
Responsibilities
Competencies
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Regulatory Affairs Executive
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Lead- Regulatory Affairs
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Permanent Michael Page- Mumbai
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Quality Assurance and Regulatory Affairs
IF MedTech Pvt Ltd- Navi Mumbai
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Executive / Senior Executive/ Assistant Manager - Regulatory Affairs US Market
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Allied Blenders & Distillers Ltd.- Mumbai
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Right Advisors Private Limited- mumbai
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Acme Services- Mumbai
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Executive-RA
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Abbott Laboratories- Mumbai
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Corenza- mumbai