Manager, Start-up and Regulatory Affairs

The Manager, Study Start Up and Regulatory is responsible for developing the strategy based on regulatory requirements and for completing study start-up and regulatory deliverables based on an established regulatory SSU RA management plan. They actively assist senior management in securing new business by participating to BDMs and contributing to proposals/budgets. They also provide strategic guidance, training, coaching and mentoring to junior members; may be required to line manage members of staff. Main responsibilities include: Assume leadership and functional representation for projects and/or deliverables of medium/high complexity ensuring effective and rapid coordination and management and execution of SSU/regulatory tasks, driving the team to meet the agreed targets and to comply with the agreed procedures, trackers and templates. Develop strategy and manage set up activities ensuring compliance and consistency with department standards. Support team members in preparing project strategy, identifying issue and providing resolution. Provide strategic input to internal and external customers and promptly identify and address any risk/potential risk by implementing preventive measures. Problem solve and ensure satisfactory resolution of performance issues or delivery failures.