Job Description Asst Manager-Regulatory Affairs

Department: Regulatory Affairs

Job Location: Ahmedabad

Job Type: Full Time

Job Purpose

The candicate will be responsible for managing regulatory activities associated with Marketing Authorisation Applications (MAAs), including preparation regulatory documents, coordination of deficiency responses, regulatory query management, and provision of regulatory support to cross-functional teams. The role will involve close collaboration with internal teams, Contract Manufacturing Organisations (CMOs), external partners, consultants to ensure timely and compliant regulatory responses.

Key Responsibilities

1. Manage and coordinate deficiency responses for Marketing Authorisation Applications (MAAs), ensuring timely, accurate, and compliant response prepapration/review.

2. Prepare, compile, review, high-quality regulatory documents, ensuring accuracy, consistency, completeness, and compliance with applicable regulatory guidelines and requirements.

3.



Ensure timely preparation and submission of responses to queries and requests for information received from relevant regulatory authorities.

4. Develop scientifically sound justifications, responses, and regulatory arguments to effectively address regulatory queries and deficiencies.

5. Collect, analyse, and critically evaluate scientific, technical, and clinical data to support regulatory submissions, deficiency responses, and regulatory strategies.

6. Review GMP-related documentation received from Contract Manufacturing Organisations (CMOs) to ensure completeness, accuracy, and compliance with applicable regulatory requirements.

7. Ensure appropriate regulatory documentation practices and maintain compliance with applicable global regulatory standards, guidelines, and internal procedures.

8. Provide regulatory support and guidance to internal cross-functional teams, including Quality, R&D;, Supply Chain, Commercial, and other relevant functions.

9. Collaborate effecti

📌 Regulatory Manager (Ahmedabad)
🏢 Orbit Pharmaceuticals
📍 Ahmedabad