Regulatory Affairs Executive - Pharma Company - Ahmedabad

Position: Regulatory Affairs – Senior & Junior
Qualification: B.Pharm / M.Pharm
Experience: 3–4 years in the same department
Openings: 1 Senior, 2 Junior
Salary Range: ₹30,000 – ₹50,000 per month (based on experience)
Location: Ahmedabad

Key Responsibilities:

• Review dossiers prepared by executives/trainees and submit to clients along with artworks for markets such as Asia, LATAM & ROW.
• Handle renewals of Registration Certificates for various countries.
• Ensure compliance of products with current ICH and country-specific guidelines.
• Arrange and courier legalized documents (COPP, FSC, POA, Manufacturing Agreements, Declaration letters, GMP certificates) to clients/countries.
• Coordinate the courier of samples for new registrations and renewals for reanalysis and commercial batch testing.
• Arrange required samples and legal documents from Legal, Production, and FRD teams.
• Follow up with FRD and Microbiology departments for client-specific testing requirements.
• Arrange and dispatch Working Standards from QC to clients/countries for testing purposes.
• Resolve client queries related to new registrations and renewals in accordance with country requirements.
• Maintain country-specific global status sheets for new registrations, renewals, and query status.
• Coordinate with the Artwork department for review and corrections of artworks for new registrations and renewals.
• Follow up and arrange documents for dossier preparation from QA, QC, ARD, and Microbiology departments as per guidelines.

Desired Skills:

• Strong knowledge of regulatory documentation and country-specific guidelines.
• Excellent coordination, follow-up, and communication skills.

Detail-oriented with the ability to handle multiple projects simultaneously.

With Regards,
Himani(HR)
9377165778

Job Types: Full-time, Permanent

Pay: ₹25,000.00 - ₹50,000.00 per month

Work Location: In person