Associate Director , Regulatory Affairs

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From MSD’s original posting

Job Description Associate Director, Regulatory Affairs Registration of products for the Indian Market. To ensure compliance to all applicable laws and regulations in respect of Own and Contract Manufacturing of Company’s product. To ensure full Compliance to Internal Compliance policy. Development of Dossiers for export and local market. To liaise with concerned authorities for the above. To represent company in various Industry Forums. Strategic initiatives for new product developments through gap analysis. Strategic initiatives by identifying opportunities for improving the market share for company’s business. ROLE RESPONSIBILITIES Primary responsibilities critical to the performance of the role. • Registration of Imported Pharmaceuticals and Vaccines. • Registration of local Biological & pharma Products. • Development of dossiers of local Biological and Pharmaceutical products for Export markets. • Renewal & maintenance of all licenses - GMP/Manufacturing/Wholesale & others owned by company & CMO. • Regulatory compliance to import products for clinical trials & CDTL testing. • Providing requested documents for registration of products in Export markets & approving all artworks &…