Job Description

Name of the Department

Regulatory Affairs

Designation

Regulatory Affairs Executive

Qualification: M. Pharm

Reporting to

Head- Regulatory Affairs

Primary Responsibilities:

1. Provide responses to the regulatory agencies regarding Product information or issues.

2. Review and compilation of the dossiers data.

3. To coordinate with respective parties to resolve the queries as and when required.

4. Continuous follow up with Loan license party and fulfill the requirements of dossiers.

5. To prepare the dossiers as per respective country guidelines (CTD, ACTD and non CTD Format).

6. Assess product labels and patient information leaflets.

7. Develop regulatory strategies and implementation plans for the preparation and submission of new product.

8. Investigate product compliance and prepare documentation and submission to appropriate regulatory agencies as necessary.

9. To check the legalized documents and submit to clients on regulatory bodies

10. Proper communication with external and internal vendor.

11. To coordinate with respective parties to resolve the query as and when required.

12. Preparation of the process validation protocol and reports.

13. Preparation of the product development report.

14. Review of Vendor Qualification documents

Secondary Responsibilities:

15. Department in-time and out-time should be followed as decided by personal and administration department.

16. Maintain current knowledge of relevant regulations, including proposed and final rules.

17. Review of the Dossier's data.

18. Ensuring that the company's products comply with regulations of the WHO guidelines.

19. Working with specialist computer software and resources.

20. Manage activities such as audits, regulatory agency inspection or product bodies.

21. Daily and Monthly progress report.

22. Knowledge of business and Management principles involved in strategic planning, resource allocation, human resource modeling, leadership technique, production methods and coordination of people and resources.

23. The ability to work under pressure and strict deadlines.

24. To Coordinate with F&D department for registration sample preparation and submit samples to regulatory bodies on time.

Job Type: Full-time

Pay: ?15,000.00 - ?40,000.00 per month

Benefits:

• Paid time off

Schedule:

• Day shift

Education:

• Master's (Required)

Experience:

• total work: 2 years (Required)

Work Location: In person

Application Deadline: 31/12/2024
Expected Start Date: 08/01/2025