Regulatory Affairs Executive

2 days ago


Surat, Gujarat, India Trident Lifeline Full time ₹ 5,00,000 - ₹ 15,00,000 per year

ONLY EXPERIENCE CANDIDATE CAN APPLY

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. Responsibilities include dossier preparation, label review, and coordination with departments for

regulatory submissions.

Key Responsibilities:

1. Handle regulatory documentation and submissions for Pharmaceutical Products (domestic &

export).

2. Prepare dossiers, technical files, and product registrations as per domestic (FSSAI, CDSCO & Etc.) and

international regulations.

3. Ensure products comply with all legal and regulatory requirements of India and specific export markets.

4. Regulatory handling and submission Basic knowledge of LATAM & ROW market registration procedures

Review product labels, artworks, and marketing materials to ensure regulatory compliance.

5. Liaison with internal departments (R&D, QC, QA, Marketing) for compiling regulatory documents.

6. Maintain up-to-date knowledge of changing regulations in export markets.



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