Associate Director , Regulatory Affairs

About the role

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.

What you'll do

• 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

What you need

• 15–27 yrs of experience
• Regulatory affairs
• Product knowledge
• Clinical research
• GMP
• Safety management
• Documentation
• Any graduate