Job Summary:
The purpose of this role is to lead regulatory device strategists to asses/assist Global Regulatory Leads (GRLs) to define the global submission strategy for the Devices CMC team within GRA-India Strategy. He/she needs to provide strategic guidance to assigned projects through a team of regulatory strategists responsible for authoring regulatory submissions and supporting maintenance/compliance activities for devices and combination products; modelling strong mentorship and project management techniques to the Devices CMC team assuring a global focus of goals, strategies and plans. As a lead he/she is directly accountable for ensuring regulatory deliverables of the assigned products in accordance with time, cost and quality expectations for all projects in portfolio through collaborative working relationships with global CMC leads, GRLs and other stake holders (PGS, BTxPS, PTxPS, and external partners). The colleague is responsible for mentoring junior colleagues as and when required and contribute to overall management, alignment and process improvement and drive the appropriate culture and behaviors through the organization in accordance to the Pfizer values.
Job Responsibilities:
The major duties and responsibilities are as below:
Functions as senior member for the Devices programs and life-cycle management (LCM) regulatory responsibilities for Devices CMC team, GRA-India Strategy Group. The responsibilities include but not limited to,
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