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Global Regulatory Affairs (GRA) develops and executes innovative regulatory strategies to provide life-changing therapies to patients. GRA has a strategic role in all stages of global product development and across the Takeda Enterprise

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
• Ensures oversight and tracking of CTA activities and eTMF updates performed by the CRO Regulatory Lead. Works in collaboration with CRO to ensure compliance
• 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
• Manages or leads CTA interactions with regional health authorities under limited senior oversight
• Mentors team members and provides direction, support, and strategic guidance to fulfil scope of project work, when applicable
• Oversees CTA interactions with health authorities in the region during assessment of clinical trial applications
• May act as deputy to Head International Regulatory Clinical Trials and Team Lead
• Demonstrates Takeda leadership behaviors and encourages the team to live up to the Takeda Code of Conduct and leadership behaviors
• Independently manages, plans, and works closely with Takeda Global and Regional counterparts, as applicable to manage all aspects of assigned CTA regulatory activities throughout the development lifecycle
• Presents regional CTA regulatory strategies to leadership/senior management
• Identifies regional/national requirements to support submissions of CTAs to Regulatory Authorities
• Coordinates submission preparations process and creation of administrative documents to support initial CTAs or maintenance submissions for the assigned interventional trials (in collaboration with CROs where applicable), ensuring all necessary documentation is made available for submission and internally approved as appropriate
• Coordinates submission preparations process and creation of administrative documents to support initial Non-Interventional Post-authorisation safety studies (PASS) and/or maintenance submissions (in collaboration with CROs where applicable), ensuring all necessary documentation is made available for submission and internally approved as appropriate
• Proactively builds/strengthens external stakeholder (Regulatory Agency where applicable, external experts, industry organizations, etc.) contacts/influence to achieve Takeda strategic goals and objectives
• Ensures accurate and timely submissions and proactive communication of key regulatory milestones throughout clinical trial lifecycle (e.g., submission and approval of initial CTA, amendment/modification, HA questions/responses etc.)
• Provides regulatory oversight of CRO activities as applicable to ensure that all submissions activities are tracked, and appropriate systems are maintained in a compliant manner (e.g., eTMF)
• Supports non routine submission activities and deviation follow-up as needed (e.g., provision of Serious Breach submissions, submission of inspection reports, ad-hoc unexpected filings etc.)
• Upon request, provides ad-hoc guidance to teams related to latest submission requirements and experiences for clinical trials
• Works as part of team to provide proactive solutions to problems arising during the CTA processes in conjunction with senior team member and/or Global/EU Regulatory Lead, as applicable
• Contributes to the maintenance of appropriate internal regulatory knowledge data base on emerging information and trends with regulators for clinical trials
• Coordinates submissions in the CTIS portal
• May represent the Team in Workshops/cross-functional initiatives and contribute/lead from clinical trials’ perspective
• Ensures involvement of Local Operating Companies (LOCs) RA representatives in HA interactions related to CTA activities, as appropriate