Talent.com
Regulatory Affairs Specialist – (APAC & RoW)

Regulatory Affairs Specialist – (APAC & RoW)

vueverse.Kottayam, IN
12 hours ago
Job description

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.
    • Create a job alert for this search

    Regulatory Specialist • Kottayam, IN