Manager – Regulatory Affairs

Job Title: Manager – Regulatory Affairs
Department: Regulatory / Quality Assurance
Reports To: Head – Regulatory Affairs / QA Director
Location: Ahmedabad

1. Regulatory Submissions & Approvals

2. Compliance & Documentation

3. Liaison & Coordination

4. Audits & Inspections

5. Strategy & Risk Management

Qualifications & Experience

• Education: Bachelor’s/Master’s degree in Pharmacy, Life Sciences, Biotechnology, or related field.

*

• Experience: 7–12 years in regulatory affairs, with at least 3 years in a managerial role.

*

• Preferred Knowledge:
• National (CDSCO, BIS, State FDA) and international (US FDA, EMA, TGA, MHRA, etc.) regulatory frameworks.
• Medical devices/pharmaceuticals/biotechnology (as applicable).

• Key Performance Indicators (KPIs)
• Timely submission and approval of regulatory applications.
• Zero non-compliance observations in audits.
• Successful market entry for new products.
• Efficient coordination with authorities and internal teams.

*
*

Job Type: Full-time

Pay: ₹2,000,000.00 - ₹2,200,000.00 per year

Benefits:

• Leave encashment
• Provident Fund

Work Location: In person