Senior Regulatory Affairs Lead

3 weeks ago


Dadra and Nagar Haveli, India SUN PHARMA Full time

Job Title:

Sr.Executive - RA

Job Grade:

G11B

Function:

Plant Regulatory Affairs

Sub-function:

Plant Regulatory Affairs

Manager's Job Title:

DGM

Location:

Dadra

Job Summary:

Manage regulatory affairs functions at site, ensuring compliance with regulations and standards.

Key Responsibilities:

1. Monitor documents for new product filing, re-registration, and renewals from plant dossier filing, sample requirements, and other regulatory submissions.

2. Participate in action plan discussions for queries from regulatory agencies and monitor submissions of data/documents from the plant.

3. Coordinate with CRA, ADD, FDD, MSTG, PMO, plant team, and other CFT members for regulatory requirements related to registration, re-registration, queries, and variation filing.

4. Product Life Cycle Management: Participate in change control committee meetings, discuss with stakeholders, and decide on final variation categories.

5. Variation management: Track variation filings, approvals, and intimation to the plant for implementation of changes.

6. Support plant business continuity by filing variations wherever applicable.

7. Monitor circulation of regulatory approvals and commitment details to plant teams for US and OAM and approval packages for emerging markets.

8. Participate in launch discussions with plant CFT, business teams, and CRA to identify gaps and mitigation plans.

9. Circulate regulatory strategies and guidelines wherever applicable.

10. Support plant during regulatory inspections.



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