Location: Vatva GIDC
Experience: 0 to 3 Years
Industry: Pharmaceutical
Key Responsibilities
Prepare and manage export regulatory documentsas per international requirements.
Compile and maintain product dossiersfor export registrations.
Coordinate with Production, QA, and QC departments to collect required documents for dossier preparation.
Follow up on regulatory samples required for product registration.
Prepare and review Package Inserts (PIs)for export products.
Coordinate with the Regulatory Affairs (RA) departmentfor permissions, COPP, FSC, and other regulatory certificates.
Maintain and track export orders and regulatory status.:
Coordinate with the Production Department on a weekly basis to ensure regulatory alignment.
Prepare and compile regulatory reports and documents such as SPEC, MOA, MFR, Stability Data, and related records.
Required Skills & Competencies
Basic to positive knowledge of international regulatory affairs and export documentation
Robust coordination and follow-up skills
Attention to detail and documentation accuracy
Ability to work cross-functionally with multiple departments