Head of Regulatory Affairs

Job Title

Head of Regulatory Affairs- ISC

Job Description

Head of Regulatory Affairs

The India Subcontinent (ISC) Regulatory Affairs Lead manages RA staff and RA activities across ISC. He/she is also responsible for ensuring compliance with RA processes and regulations, company policies and procedures, establishing best practices, and representing the company for any safety, regulatory or compliance issues. The RA Lead is also responsible for interfacing with HQ, RA Business Leads, , labelling, business process leads, Global Medical Affairs, marketing teams, and other business units to ensure alignment on issues impacting RA activities.
This role will oversee a team of RA professionals to ensure business objectives are met.
Specifically, as a senior leader, the incumbent will actively provide input to regulatory strategy for ISC and the region starting from new product introduction and Life Cycle Management (LCM) activities.

Responsibilities

Additional representative responsibilities will include, but not necessarily be limited to, the following:

• To formulate and implement the Businesses and / or Markets long-range regulatory strategies and policies....