Regulatory Affairs Specialist –

4 hours ago

india, IN vueverse. Full time

Key Responsibilities:


Regulatory Submissions & Compliance

  • Author, compile, and submit regulatory dossiers to global health authorities, including USFDA, EMA, MHRA, TGA, HSA, NPRA, Thai FDA, Taiwan FDA, CDE, NMPA, PMDA, and others.
  • Conduct dossier gap analysis to identify document and data gaps across all CTD modules (1–5).
  • Convert and prepare dossiers in multiple formats including eCTD, ACTD, and CTD.
  • Manage end-to-end preparation and submission of ANDA, NDA, BLA, MAA, and other lifecycle submissions (variations, renewals, withdrawals).
  • Coordinate responses to health authority queries through cross-functional collaboration and data collation.
  • Maintain a strong command over CMC, clinical, non-clinical, and administrative documentation to ensure successful global submissions.

Project Planning & Management

  • Manage regulatory submissions for multiple products across multiple countries simultaneously.
  • Utilize project management tools to track project milestones, timelines, and deliverables.
  • Ensure efficient time and resource allocation to meet submission deadlines.
  • Foster seamless communication between central regulatory, regional teams, and client stakeholders.


Requirements:

  • 8–10 years of core experience in Regulatory Affairs, handling submissions across regulated and RoW markets.
  • Strong understanding of global dossier formats, submission pathways, and lifecycle management.
  • Excellent cross-functional communication and coordination skills.
  • Proven ability to manage complex multi-country regulatory portfolios.

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