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  • Assistant Manager- Regulatory Affairs - Mumbai - Domnic Lewis Private Limited

    Domnic Lewis Private Limited
    Domnic Lewis Private Limited Mumbai

    1 month ago

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    Description

    Job Description: We are seeking an Assistant Manager- Regulatory Affairs and Pharmacovigilance to support a Global Pharmaceutical MNC based in Mumbai.

    Position: Assistant Manager- Regulatory Affairs (Domestic Market)

    Key Responsibilities:

    • Maintain and upload data to Health Authority databases, including SUGAM and FDA
    • Compile and submit applications for product registration, such as drugs, medical devices, and food supplements
    • Handle CMC queries and lifecycle management, including labeling, license renewals, and artwork reviews
    • Develop and implement regulatory strategies for export markets and ensure compliance with CDSCO and international regulations
    • Support inspections, audits, and internal Quality Management Systems (QMS)
    • Manage product complaints, recalls, and suspected falsified products
    • Maintain global and local regulatory databases

    Requirements:

    • B.Pharm/M.Sc. degree with 7+ years of experience; MBBS/M.Pharm/Ph.D. preferred
    • Strong understanding of CMC, non-clinical, and clinical data; proficiency in MS Office; excellent communication and organizational skills
    • Knowledge of regulatory requirements, drug development, risk-benefit analysis, adaptability, and teaching ability

    Key Attributes:

    • Professional discretion, ability to work independently, attention to detail, and enthusiasm for maintaining high standards in regulatory and pharmacovigilance activities

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