Regulatory Affairs Specialist

0 years

2 - 3 Lacs

Posted:1 day ago| Platform: GlassDoor logo

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Work Mode

On-site

Job Type

Full Time

Job Description

We are looking for a Regulatory Affairs Executive with strong knowledge of pharmaceutical products. The candidate must have experience in domestic regulatory compliance (FSSAI/CDSCO) and export documentation, specifically for LATAM & ROW. Responsibilitiesinclude dossier preparation, label review, and coordination with departments for regulatory submissions.

Key Responsibilities:

Handle regulatory documentation and submissions for Pharmaceutical Products (domestic & export). Prepare dossiers, technical files, and product registrations as per domestic (FSSAI, CDSCO & Etc.) and international regulations. Ensure products comply with all legal and regulatory requirements of India and specific export markets. Regulatory handling and submission Basic knowledge of LATAM & ROW market registration procedures Review product labels, artworks, and marketing materials to ensure regulatory compliance. Liaison with internal departments (R&D, QC, QA, Marketing) for compiling regulatory documents. Maintain up-to-date knowledge of changing regulations in export markets.

Job Types: Full-time, Permanent

Pay: ₹20,000.00 - ₹25,000.00 per month

Benefits:

  • Cell phone reimbursement
  • Health insurance
  • Paid sick time
  • Paid time off
  • Provident Fund

Work Location: In person

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