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
- Strong coordination and follow-up skills
- Attention to detail and documentation accuracy
- Ability to work cross-functionally with multiple departments