Associate Director, Senior International Clinical Trial Regulatory Lead

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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.  
• 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.

Accountabilities:

• 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.
• Participates in reviews and may co-author internal procedures and processes, as appropriate. 

Education & Competencies (Technical and Behavioral):

• BSc. Advanced scientific related degree preferred; BA accepted based on experience.
• A minimum of 8 years of hands-on experience in regulatory affairs, including active involvement in the execution of clinical trials.
• Demonstrated expertise in leading the preparation and submission of regulatory documents to support clinical trial applications and amendments within the EU regulatory framework.
• Strong understanding of the European pharmaceutical development lifecycle and associated regulatory standards; familiarity with non-EU regulatory landscapes is a plus.
• In-depth experience with regulatory submissions and comprehensive knowledge of the Clinical Trials Regulation (CTR) and Clinical Trials Information System (CTIS).
• Proven track record in project leadership and management, with exposure to team supervision and coordination; prior people management experience is advantageous.
• Excellent written and verbal communication abilities, with a proactive approach to sharing insights and fostering knowledge exchange.
• Recognized capability to lead cross-functional teams and cultivate effective, collaborative relationships across diverse organizational levels.
• Motivated to contribute to a dynamic, fast-growing team that values integrity, fairness, honesty, perseverance, and teamwork.
• Experience supporting regulatory authority inspections and proficiency in the conduct of GxP audits will be advantageous.
• Able to manage with limited supervision different types of regulatory development procedures in the region.
• Can speak up and is perceived as a natural, assertive authority whom peers trust for their advice.
• Communicates externally/with authorities in concise and respectful language.
• Develops concise strategic plans, understandably outlines the opportunities and risks of alternative scenarios before proposing a decision.
• Proposes risk mitigation plans.
• Acts as an ally to support individuals as a whole and promotes an inclusive culture.
• Practices active listening encourages open dialogue, feedback, and diverse opinions.
• Is able to prioritise activities and execute within reasonable time with limited supervision.
• Can take tactical decisions.
• Adapts to changing circumstances and is able to build and maintain relationships.
• Has their voice heard as remote participant to global or cross functional teams; influences meeting agendas & outcomes to optimally integrate regional strategic needs.
• Receives and gives feedback; expresses ideas, questions, and disagreement.
• Is self-aware and able to function effectively while meeting the multiple challenges of daily life with a sense of energy, vitality, and confidence.
• Fluency in English

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