Senior Regulatory Affairs Specialist

1 day ago

Mumbai, Maharashtra, India beBeeCompliance Full time ₹ 1,20,00,000 - ₹ 2,00,00,000
Job Overview:

  The successful candidate will lead all regulatory affairs activities at a manufacturing site, ensuring timely and accurate regulatory submissions, compliance with national and international regulations, and providing strategic support to institutional and international business operations.

Main Responsibilities:
  • Regulatory Compliance and Planning:
    • Develop and implement effective regulatory strategies to ensure site compliance with applicable national regulations and standards.
    • Prepare and submit various applications such as product permission, layout approval, facility modification approval, technical person approval, test license, amendments in licenses, state GMP and GLP certificate applications, post-approval changes etc. to health authorities.
    • Evaluate technical and scientific data for regulatory submissions.
    • Liaise with health authorities for inspections, clarifications, and approvals.
  • Product Support and Documentation:
    • Handle product complaints from regulatory authorities, coordinating with QA, Legal, SCM, and Manufacturing for resolution.
    • Provide regulatory support for internalization and externalization of products.
    • Provide site CMC documents to international business team to support export registration.
  • Quality Oversight and Governance:
    • Maintain and update regulatory databases, trackers, licenses, and approvals.
    • Review and track regulatory impact of quality documents such as change controls, deviations, FLQRs, and product certifications.
    • Evaluate and approve site change controls and Change Request evaluation forms.
  • Tender Certificates and Compliance:
    • To obtain NCC, manufacturing & marketing certificates, and CMC documents to support institutional and international business.
    • Coordinate with Institutional business team and site team for documentation as well as to facilitate site inspection of tendering authority.
  • Governance, SOPs, and Training:
    • Support the preparation, revision, and implementation of Regulatory SOPs and work instructions.
    • Deliver training on GMP, regulatory updates, and SOPs at the site level.
    • Approve SCNs from Corporate QA and review reports from regulatory authorities.
  • Additional Responsibilities:
    • Complete assigned trainings on time
    • Perform other duties as assigned by the Regulatory Affairs leadership.
    • Act as the regulatory lead for the site, ensuring alignment with corporate and regulatory expectations.

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