Regulatory Affairs Manager

1 week ago

Daman, Daman and Diu, India BioTalent Search® Full time ₹ 9,00,000 - ₹ 12,00,000 per year

Our client is a
leading global organization in Women's Health
with a strong focus on contraceptive and reproductive healthcare solutions. With state-of-the-art manufacturing facilities and in-house R&D expertise, the company has developed innovative medical devices and solutions that have empowered millions of women worldwide. The organization is certified under
ISO 9001, ISO 14001, WHO GMP, CE, and ISO 13485
standards.

Job Description – Manager, Regulatory Affairs (RA)

Location:
Daman

Experience:
12+ Years (relevant regulatory affairs experience)

Qualification:
M.Pharm

Key Responsibilities

  • Develop and implement
    global regulatory strategies
    to ensure timely product approvals and market access across multiple health authorities (FDA, EMA, MHRA, TGA, Health Canada, etc.).
  • Provide
    regulatory intelligence
    and strategic advice to senior management on evolving regulations and their potential impact on business.
  • Collaborate with
    R&D, Quality, Manufacturing, and Marketing
    teams to align regulatory activities with overall business goals.
  • Prepare, compile, and submit
    Controlled Correspondence, Pre-submission Meeting Requests, and Scientific Advice
    for US, EU, Canada, and other global markets.
  • Evaluate
    pre-PIFs
    and provide regulatory submission requirements for US & EU, with extended submissions for Australia, Canada, and other regions.
  • Define and implement regulatory strategies to ensure
    business continuity and Day 1 launches
    in Europe, Canada, Australia, UK, China, and other key markets (Type IA/IB/II Supplements, Category 3 Notifications).
  • Act as a
    CMC expert
    for initial submissions and lifecycle management in global markets (US, EU, Canada, Australia, China, and emerging regions) across multiple dosage forms:
    OSDs, Ophthalmics, Complex Injectables, and Liposomal products
    .
  • Author and review
    CMC documentation
    (dossiers, technical files, deficiency responses), ensuring technical accuracy and compliance with agreed regulatory strategies.
  • Lead
    cross-functional teams
    for new product development, regulatory submissions, and post-approval lifecycle management.
  • Ensure ongoing
    compliance with international regulatory standards
    ; manage audits and inspections by global authorities.
  • Manage and mentor the
    Regulatory Affairs team
    , ensuring compliance with applicable guidelines for pharmaceuticals and biologics (ANDA, NDA, DCP, CP, ANDS applications).
  • Conduct regulatory evaluations of
    change controls, deviations, OOS/OOT events, and other quality incidents
    to assess regulatory impact.
  • Utilize and oversee
    regulatory software systems
    such as
    LIMS, TrackWise, PharmaReady, Amplexor
    , etc.

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