Vacancy at The Himalaya Drug Company For Associate Domestic Regulatory Affairs...
About the Company
Working in the Himalayas means to learn and grow continuously. Opportunities to work on the finest ever products in the herbal space, competitive salaries and excellent benefits. We offer challenging assignments, a world-class working environment, professional management and ample prospects to train and learn along with exceptional rewards.
Job description
- The compilation, filing, and approval of all interim and final license/registration/Market authorization applications for Health/Cosmetic category products for domestic and export sales.
- Regulatory follow up with regulatory authorities like CDSCO, State FDAs, Deptt of AYUSH, Port and Zonal offices of CDSO and Govt labs, Biodiversity for application under process Ensuring the preparation, maintenance and update of product registration/license and regulatory compliance files.
- Managing and maintaining a regulatory documentation filing system.
- Coordinating of Certificates of Free Sales, WHO GMP & other quality certifications, etc.
- Developing and maintaining a database of local regulatory requirements.
- Ensuring the compilation of dossiers for submissions to authorities working closely with company personnel (e.g., R&D SSG, Category R&D, Plant QA, etc.) and contractors, as required.
Education
UG :B.Pharma in Pharmacy, B.Sc in Any Specialization
PG: M.Pharma in Pharmacy, MS/M.Sc(Science) in Any Specialization
Job Location: Bengaluru.
Key Skills
regulatory affairs domestic regulatory affairs regulatory compliance.
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