Associate Director, Senior International Clinical Trial Regulatory Lead

Das ist der Job

Ensures oversight and tracking of CTA activities and eTMF updates performed by the CRO Regulatory Lead.

Darum lohnt es sich

Provides strategic and tactical advice and guidance and CTA regulatory expertise to regional and global leadership teams on how to achieve timely and efficient conduct of assigned development programs while maintaining full compliance with applicable regulatory requirements.

Mentors team members and provides direction, support, and strategic guidance to fulfil scope of project Job Description Objective / Purpose Contributes to the development of regulatory strategy for assigned clinical trials in Europe & Canada (EUCAN) and Growth & Emerging Markets (GEM) regions.

Develops the operational implementation plan for clinical trial applications (CTAs) in EUCAN and GEM regions from initial submission throughout lifecycle, in alignment with the global submission strategy.

This may concern trials across a variety of Therapeutic Areas, including oncology, gastrointestinal and inflammation, marketed products and neuroscience.

Executes or oversees all activities related to the creation, submission, and maintenance of CTAs Globally (GEM and EUCAN region), in Europe through the EU Clinical Trial Information System (CTIS) or legacy processes in conformity with legal requirements and with Takeda’s global and regional internal procedures.

Works in collaboration with CRO to ensure compliance. Manages or leads CTA interactions with regional health authorities under limited senior oversight.