Sr. Officer

Department: Regulatory Affairs

Designation : Sr. Officer

Experience : 1 to 4 years

Highest Qualification: M. Pharm

Roles & Responsibilities:

1. Prepare, compile, and review regulatory dossiers for submission.

2. Respond to queries and deficiency letters from regulatory authorities in

coordination with technical teams.

3. Co-ordinating with cross-functional teams like R&D, QA/QC, production to

collection of data for submissions.

4. Maintain regulatory files and track submission and approval status using

internal systems.

5. Provide regulatory input during product development, scale-up, and lifecycle

management.

6. Supporting the review of product labels, cartons, and inserts to ensure

compliance with regulations.

7. Ensure products comply with all regulatory requirements through each stage of

development and commercialization.

8. Conduct training sessions on regulatory updates and internal System

9. Ensure documentation is audit-ready and aligned with internal SOPs and

regulatory expectations.

10. Support internal and external audits by providing required regulatory

documents and justifications.

11. Guide and review work of junior team members or trainees.

12. Review and interpret regulatory guidelines and notify stakeholders of relevant

updates.