Regulatory Affairs Role - Orals - Pre Approval/Post Approval - Pharmaceutical Firm

Regulatory Affairs Role - Orals - Pre Approval/Post Approval

We are looking for a Regulatory Affairs US/Canada - Pre-Approval / Post Approval _ Bangalore role for a Global Pharmaceutical company at Bangalore.

Role & responsibilities :

Formulation RA US/Canada -Pre-Approval:

- Preparation, review & timely submission of ANDA in US.

- Deficiency & life cycle management for products filed in US.

- Providing necessary regulatory inputs to different cross functional teams (including CMO & CDMO projects).

Formulation RA Global Post - Approval:

- Preparation, review & timely submission of Supplements/variations for global mkts.

- Preparation, review & submission of Post approval Deficiency management

- Handling Change control assessments to provide necessary regulatory inputs for the changes/strategies proposed.

- Preparation, Review, compilation & submission of PADER/PSURs & Annual Report for all approved products across geographies as applicable.

Industry Type: Pharmaceutical

Department: Regulatory Affairs

Employment Type: Full-time Role

Category: Research and Development

Educational Background Required: B Pharm, M Pharm

Key Skills: Regulatory submissions, Life cycle management, Cross-functional collaboration