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  • Manager - Corporate Regulatory Affairs - Mumbai - Piramal Group

    Piramal Group
    Piramal Group Mumbai

    1 week ago

    Default job background
    Full time
    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:

    • 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

    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

    1. Compilation and submission of Abbreviated New Drug Applications (ANDAs) in CTD format for US and other markets as per respective regulatory requirements
    2. Compilation of responses pertaining to CMC, Dissolution, Bioequivalence, Microbiology, and Labeling deficiencies and ensuring that registration approvals are granted without undue delay
    3. Labeling, SPL, and drug listing activities
    4. Review and approval of submission-related documents such as Batch Manufacturing Records, Packaging Records, Analytical Reports, Stability reports, Technology transfer documents
    5. Drafting controlled correspondences to USFDA
    6. Due diligence of products planned for acquisition
    7. 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)
    8. Identifying the appropriate filing category for post-approval changes and submissions to USFDA
    9. Preparation of regulatory strategy documents
    10. Providing regulatory costing for new projects
    11. Participation in site audit/inspection, when scheduled
    12. Lifecycle management of approved products
    13. 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

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