Senior Regulatory Affairs Specialist

Job Profile:

• Responsible for registration of Pharmaceutical, Nutraceutical, Cosmetic products especially in international markets like ROW, MENA, SEA, LATAM etc.
• Compile, Review & Submit the Dossiers to the Distributors as per the MOH guidelines.
• Coordinating & follow-up up with the suppliers and distributors regulatory team for document review, compilation & submission to the necessary authority.
• Preparation, collation & review of the registration documents pertaining to product registrations along with query resolution.
• Follow up and coordinate with various departments across the company to collate documents required for regulatory submissions on time.
• Preparing and maintaining a regulatory budget sheet, product registration records.
• Draft policies and SOPs for the company from a Quality perspective.
• Prepare and approve labelling & artwork as per specific country requirements for domestic and export markets.

Education & Experience:

• Bachelors in B. Pharm (preferred) or any other science graduate.
• Minimum 1- 3-year experience in International Registration.
• Immediate joining is preferred.
• Excellent Written & Verbal English communication.
• Self-starter & energetic.