Senior Executive- Regulatory Affairs, ROW

Locations --
Mumbai, India
Business Area/Department --
Regulatory
Contract Type --
Permanent

1. Planning and preparation for Renewals / annual maintenance of MA’s assigned; ensure all regulatory requirements of health authorities are met and supply continuity for the products are maintained.

2. Assessing Change request assigned to ensure regulatory assessment along with strategy and documents required for any regulatory submissions are shared with stakeholder in a timely fashion.

3.Ensure meeting other regulatory obligations like submission of PSUR, Sunset clause applications as and when applicable, working cross functionally to get the necessary information for submissions and informing stakeholders about submission / outcome as per defined regulatory procedures
4.Provide peer review support as and when required for submissions made by Executives/ Sr. Executives
5. Ensure prompt action in terms of compliance to departmental procedures, ensure up todate training records for self, ensure updation of regulatory databases as and when required
6. Actively drive continuous improvement initiative for team/ function as and when delegated
7. Actively drive simple to moderately complex regulatory projects (functional or cross functional)
8. Act as process owners for simple to moderately complex regulatory procedures, ensure lifecycle of the procedure taking ownership for engaging with team to train and improve upon as and when needed
9. Support Line Managers for readiness and participation of any health authority inspection
10. Actively involved in knowledge sharing and best practices across team / function and sometimes cross functional teams

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