Job Description

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