Regulatory Affairs Manager

leading global organization in Women’s Health

Location:

Experience:

Qualification:

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.