Assistant Manager Pharma Regulatory Affairs

Role & responsibilities

1. Preparation, Review, and successful submissions of CTD/e-CTD format Dossiers Module I to V in various markets like ROW, EU, ASEAN, Gulf etc. as per country-specific procedures & requirements.

2. Prepare and submit regulatory documents for product approvals, variations, renewals, and post-approval changes for our clients.

3. Collaborate with clients to develop regulatory strategies aligned with their business objectives.

4. Maintain up-to-date knowledge of regulatory requirements, guidelines, and industry trends.

5. Communicate with health authorities to address queries and facilitate timely approvals.

6. Review and interpret regulatory guidelines to ensure compliance throughout product lifecycle.

7. Participate in regulatory intelligence activities, keeping the organization informed of relevant changes.

8. Contribute to the preparation of regulatory submissions, ensuring accuracy and completeness.

9. Support regulatory inspections and audits at client sites.

10. Shall be well versed with DCGI requirements for New Drug approval

11. Review of labels of Drugs, Cosmetics and Medical Devices and ensuring their full compliance with the applicable Rules and Regulations.

12. Handling and responding to all the product specific queries.

Preferred candidate profile

1. At least 4 years of experience in Domestic Drug Regulatory Affairs.

2. Education: Science Graduate / B.Pharma / M. Pharma.

3. Industry Type: Pharma.

4. Good knowledge about the Indian Drug Regulatory System.

5. Knowledge of Dossier Modules, understanding of GMP standards and regulatory guidelines.

6. Good Interpersonal skills

7. Command over written and verbal English communication.

8. Proficient in computer skills especially MS Office and adobe PDF.

9. Commitment and ownership.

10. Proactive and problem-solving approach.

11. Ability to work with strict timelines.

12. Willingness to travel across country as and when required