Assistant Manager - Regulatory Affairs - Pharma

Assistant Manager Regulatory Affairs

Job Description:

Roles and Responsibilities:

1. Responsible for providing support and regulatory guidance to a team of RA Associates in the completion of projects supporting regulatory submissions.

2. Responsible for the preparation of quality regulatory PLCM submissions for various markets to ensure timely approval.

3. Responsible for the maintenance and timely completion of regulatory documents to support regulatory compliance in various markets.

4. Accountable for assessing, coordinating and compiling deficiency responses in a timely manner.

5. Works with other functional areas to resolve issues related to information for regulatory submissions.

6. Responsible for handling the Supplier driven changes (SDC). This involves activities such as evaluate, prepare & review of SDC related assessments.

7. Evaluate, prepare and review of post approval supplements to manage the regulatory product life cycle as applicable.

8. Review of change control documents.

9. Approval of change control documents and quality notifications as assigned.

10. Maintains regulatory databases to ensure accuracy of information.