Regulatory Affairs Manager

1 day ago

Hyderabad, Telangana, India vueverse. Full time US$ 90,000 - US$ 1,20,000 per year

Key Responsibilities
:

  • Lead and manage
    CMC regulatory activities
    for USFDA submissions including
    ANDA preparation, review, and filing
    .
  • Oversee compilation and submission of
    Annual Reports
    , amendments, and deficiency responses.
  • Interface with cross-functional teams including
    Quality Assurance, Production, and R&D
    to gather required documentation and data.
  • Review and ensure compliance of
    Batch Manufacturing Records (BMR)
    , process validation documents, and site-related data.
  • Coordinate with manufacturing units to ensure product and process compliance aligned with regulatory requirements.
  • Stay updated on evolving USFDA regulations and provide impact assessment and strategic guidance.

Key Requirements
:

  • 7–10 years of hands-on experience in
    Regulatory Affairs – CMC
    with
    USFDA filings (especially ANDAs)
    .
  • Strong understanding of
    ICH, USFDA guidelines
    , and regulatory frameworks applicable to generic drug products.
  • Experience in
    preparing and reviewing technical documents
    : Module 2 & 3 (CTD format).
  • Exposure to
    quality systems, BMR review
    , and
    interacting with production
    /plant teams.
  • Ability to handle end-to-end submission lifecycle including post-approval changes and correspondence with USFDA.

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