Sr Manager

1 month ago

Halol, India SUN PHARMA Full time

1

Monitoring for Documents compilation activities for New product filing, Re-Registration/renewals from plant for dossier filing, sample requirements etc.

2

Participation in Action plan discussion for queries from different Regulatory agencies and monitoring for submission of data/documents from plant .

3

Coordination with CRA, ADD, FDD, MSTG ,PMO ,Plant team and with other CFT Members for regulatory requirements related to Registration, Re-Registration, queries, and variation filing.

4

Product Life Cycle Management: Active participation in Change control committee meeting. – Discussion with different Stakeholders and decision for final variation category (After taking concurrence from CRA, Country RA and Customers if require).

5

Activities related to Variation management - Tracking of Variation filing, approvals and intimation to plant for implementation of changes.

6

Support plant for business continuity of products by filing variations wherever applicable.

7

Monitoring for circulation of Regulatory Approvals and commitment details to Plant Team for US and OAM and Approval package for emerging market.

8

Participation in all launch discussions with plant CFT , business team , CRA to identify gap & mitigation plan.

9

Circulation of Regulatory strategies and Guidelines, wherever applicable

10

Support plant during Regulatory Inspections.

11

Monitoring for Product permissions, test licences and lay out archival activities for Local FDA .

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