Ensure that investigations associated with assigned third party sites are properly carried out, resulting in sustainable CAPA, documented, evaluated, and closed as efficiently as possible, and in respect with the procedure.
Manage interaction with OPDP including response to regulatory inquiries or enforcement actions, preparation of complete, accurate, high quality submissions for advisory comments, and discussion with OPDP staff on requested changes.
This role requires a cross - matrix leader to contribute to an integrated strategy across different indications for company'916, and to combination strategies with various internal and external assets.
Ensure the development of appropriate regional regulatory strategy( s ) and their execution for assigned asset( s ) consistent with Medicines Development Strategy and ensure compliance with both government and internal company process / policies.
The candidate will be responsible for leading clinical development team( s ) consisting of physicians, clinical scientists and other function representatives, strategizing development plan, executing clinical trials, and managing the development resources and timeline.
The role will also have a responsibility to establish a structure which can execute against the known and expected demand roadmap and directly support the business objectives underpinned by Digital Analytics and Media solutions.