Drug Regulatory Affairs Officer New Delhi

Drug Regulatory Affairs Officer New Delhi

07 Aug
|
Akums Drugs & Pharmaceuticals
|
New Delhi

07 Aug

Akums Drugs & Pharmaceuticals

New Delhi

Role & responsibilities

1- Prepare and review, and submit regulatory dossiers for product registrations under guidance of Mentor

2- Ensure compliance with regulations issued by Central Drugs Standard Control Organization (CDSCO) and other global regulatory authorities.

3- Prepare and maintain CTD/eCTD, DMF, and product registration documents.

4- Coordinate with cross-functional teams including R&D; and Portfolio team

5- Review product labels, packaging materials, and Scientific literature for regulatory compliance.

6- Monitor changes in regulatory guidelines and communicate their impact to relevant departments.

7- Support lifecycle management activities such as variations, renewals, amendments, and change controls.

8- Respond to regulatory authority queries and provide required documentation within timelines.

9- Maintain regulatory databases and document management systems.

📌 Drug Regulatory Affairs Officer New Delhi
🏢 Akums Drugs & Pharmaceuticals
📍 New Delhi

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