Regulatory Affairs Executive

3 days ago

Chennai, India Medopharm Full time

Job Description: Regulatory Affairs Executive (ROW Markets)

Industry: Pharmaceuticals

Experience: 3-5 Years

Loaction: Chennai

Key Responsibilities:

Dossier Submissions: Compile & submit ACTD, CTD, and country-specific dossiers for ROW markets.

Regulatory Queries: Prepare and respond to health authority queries on submitted dossiers.

Document Review: Review BMR, specifications, COA, MOA, and technical documents for compliance.

Artwork Coordination: Ensure accuracy in labeling & packaging artwork with regulatory standards.

FDA Compliance: Maintain records for FDA licenses (Product Permission, CoPP, FSC).

Legal Documentation: Track notarized & legalized documents for international submissions.

Eligibility & Requirements:

  • Education: B.Pharm / M.Pharm (Pharmacy graduates preferred).
  • Experience: 3-5 years in regulatory affairs, dossier submissions, or pharma compliance.

Skills:

  • Strong knowledge of ACTD/CTD dossier formats.
  • Familiarity with FDA, EMA, and ROW market regulations.
  • Attention to detail in documentation & compliance checks.
  • Proficient in regulatory tracking systems & MS Office.

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