Sr. Manager - Regulatory Affairs - API (Hyderabad)

Sr. Manager - Regulatory Affairs - API (Hyderabad)

27 Sep
|
Biophore
|
Hyderabad

27 Sep

Biophore

Hyderabad

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.Positive understanding of:

- CTD structure
- Global filing requirements.Strong exposure to:
- Deficiency handling (USFDA preferred)
- Customer-facing regulatory roles
- Knowledge on guidance and regulatory requirements

📌 Sr. Manager - Regulatory Affairs - API (Hyderabad)
🏢 Biophore
📍 Hyderabad

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