
Regulatory Affairs Executive
2 days ago
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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