GSK - Manager - Regulatory Affairs

1) Deliver regulatory strategy of key assets identified for India and achieve regulatory milestones according to plan for imported Rx (finished product and bulk drug), Cx and biopharma assets. This includes new product launches, line extensions, label expansions, clinical trials identified as important for India business.

2) Support GMS function by overseeing projects requiring regulatory permissions to be sought (initial and life cycle 

maintenance) to import bulk material from third party manufacturers for use at GSK's own sites as well as CMOs.

3) Support business continuity via management of renewals, CMC/ labeling variations, post approval commitments for assigned portfolio.

4) Oversee implementation of regulatory processes/systems as well as governance process within the team for assigned portfolio.

5) Promote development and growth of talent within the team.

6) Liaise with global as well as local stakeholders for regulatory requirements related to various submission activities.

7) Ensure regulatory compliance to applicable regulations in India.

Tracking of Projects:

Track and maintain the product lifecycle on local regulatory database for assigned portfolio. Track submission status & follow-up on GSK Global RA Systems as well

8) Support implementation of QMS compliant process for regulatory affairs function for the relevant identified activities.

9) Responsible for identifying, assessment, communication and acting upon all relevant Quality and Regulatory Intelligence (QRI) received from external or internal sources which may present a potential risk or opportunity to GSK, require GSK input to influence new requirements or require GSK to make changes to ways of working. Ensure relevant stakeholders at LOC and in central teams receive the relevant communication in a timely manner.

Why GSK?

Our values and expectations are at the heart of everything we do and form an important part of our culture.

These include Patient focus, Transparency, Respect, Integrity along with Courage, Accountability, Development, and Teamwork. Our goal is to be one of the world's most innovative, best performing and trusted healthcare companies. We believe that we all bring something unique to GSK and when we combine our knowledge, experiences and styles together, the impact is incredible. Come join our adventure at GSK where you will be inspired to do your best work for our patients and consumers. A place where you can be you, feel good and keep growing.

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