Manager - Regulatory Affairs - Biotechnology Firm

Industry - Pharmaceuticals

Job Type - Permanent

 Description - This is an opportunity within the Global Regulatory Affairs and Safety (GRAAS) Department located in Mumbai, India

The role also involves managing all aspects of the clinical trial application and approval process including maintenance activities for ongoing clinical trials

Client Details -

Our client is the world's largest MNC independent biotechnology firm.

The organization heaquatered in USA, is growing exponentially in India

Description - 

- The Manager of Regulatory Affairs will report to the Head of Regulatory Affairs located in Mumbai, India.

- This role is focused on supporting the execution of the organizations commercial plans in India by effectively coordinating with the commercial partner to ensure all aspects with respect to commercial applications and approvals are in compliance to corporate and local regulatory requirements.

- Coordinate and review all marketing and import registration applications complied by the business partner to ensure filing timelines and approvals from CDSCO are adhered to.

- The role also involves managing all aspects of the clinical trial application and approval process including maintenance activities for ongoing clinical trials.

- This role will ensure timely and robust functional/cross-functional coordination, transparent execution and implementation of Regulatory Affairs and safety processes and deliverables in order to support partners involved in commercialization and maintain local clinical trial authorizations.

Profile - 

Education: Bachelor's degree or Master degree in Life Sciences or equivalent or B Pharm or M Pharm