Job Description

MAIN PURPOSE OF THE ROLE



Leads/supervises a team of more than 2 professionals within the Regulatory Affairs Sub-Function.



First level manager of a work team that may comprise professionals, technical and/or administrative staff.



Typically without budget or hire/fire authority.



Focuses on mentoring, coaching, and coordination.



MAIN RESPONSIBILITIES



• As the Team Leader (Professionals) of the Regulatory Affairs Sub-Function, supervises professionals in directing development of



product registration submission, progress reports, supplements, amendments, or periodic experience reports.



• Interacts with regulatory agency to expedite approval of pending registration.



• Serves as regulatory liaison throughout product lifecycle.



• Participates in some of the following: product plan development and implementa...

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