Sr. Manager - Regulatory Affairs - API

1. This role will lead Regulatory response management, deficiency handling, and customer engagement for global filings.

2.To be a critical bridge between regulatory, customers, and business development, ensuring timely approvals and strong client relationships.

3. Regulatory Deficiencies & Approval Management

4. Customer Response Management & BD Coordination

5. Analyzing and responding to regulatory queries/deficiencies

6. customer communication and stakeholder management skills.

7.Ability to manage multiple priorities under tight timelines

8.Strong exposure to:

• Deficiency handling (USFDA preferred)
• Customer-facing regulatory roles
• Knowledge on guidance and regulatory requirements

8.Good understanding of:

• CTD structure

• **Global filing requirements.**Strong exposure to:

• Deficiency handling (USFDA preferred)

• Customer-facing regulatory roles

• Knowledge on guidance and regulatory requirements