MAIN PURPOSE OF ROLE:
Increase the support for the Mumbai based UK-IE Regulatory team by strengthening the leadership team with a regulatory professional with extensive regulatory experience in these territories.
Lead and manage projects, tracking and timely reporting of status updates to Business Stakeholders
Identify and implement processes as well as improve existing work processes followed by the team.
Act as a point of contact for Health Authorities (MHRA & HPRA) for matters specific to any investigation/inspection/SAM and other formal bodies (e.g. BGMA).
Oversee and drive centrally managed Sunset Clause monitoring process to ensure compliance with Health Authority requirements and that no licences are revoked.
Oversee and drive the MA cancellation process as required.
Lead and co-ordinate MHRA & HPRA Health Authority Inspection preparations with Mumbai based team as directed by Quality/Drug Safety.