Title: Senior Executive

Date: Sep 14, 2024

Location: Dadra - Plant

Company: Sun Pharmaceutical Industries Ltd

Name:

Employee id:

Job Title:

Sr.Executive - RA

Job Grade:

G11B

Function:

Plant Regulatory Affairs

Sub-function:

Plant Regulatory Affairs

Manager’s Job Title:

DGM

Skip Level Manager’s Title:

NA

Function Head Title:

Sr.Vice President

Location:

Dadra

No. of Direct Reports (if any)

None

Date of Joining:

Job Summary

Manage work related to Regulatory Affairs functions at Site

.

Areas Of Responsibility

1	Monitoring for Documents compilation activities for New product filing , Re-Registration/renewals from plant 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.

Travel Estimate

Up to %

Job Scope
Internal Interactions (within the organization)	Production/ Quality/MSTG/NPQC/CRA/FDD/ADD/PDD
External Interactions (outside the organization)	Customers / Country RA
Geographical Scope	Dadra
Financial Accountability (cost/revenue with exclusive authority)	N/A

Job Requirements
Educational Qualification	M.Sc. /B.Pharm/M.Pharm
Specific Certification	N/A
Skills	Believe in Team work, Leadership Skills , Communication Skills
Experience	7-8 Years