Sr. Manager - Regulatory Affairs - API

Biophore; Hyderabad; On-site; INR 1,200,000 - 1,800,000; Full time

Job summary

Biophore in Hyderabad, India, seeks a regulatory professional to lead regulatory response management for global filings. You will act as a bridge between regulatory teams, customers and business development to secure timely approvals and strong client relationships.

Responsibilities include deficiency handling (USFDA preferred), responding to regulatory queries, and maintaining CTD structures and global filing requirements while managing multiple priorities under tight timelines.

Qualifications

• Experience with regulatory responses for global filings.
• Deficiency handling and approvals processes.
• Customer-facing regulatory role experience.
• Knowledge of CTD structure and global filing requirements.

Responsibilities

• Lead regulatory response management for global filings.
• Bridge between regulatory teams, customers, and BD.
• Engage customers and manage stakeholder relationships.
• Coordinate deficiency responses and ensure timely approvals.
• Prioritize multiple tasks under tight timelines.

Skills

Regulatory strategy

Global filings

Deficiency handling

USFDA exposure

Customer engagement

Stakeholder management

Time management

Job description

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