VP, Head EUCAN Regulatory Affairs

Takeda Pharmaceutical
Red Lion, PA
Sep 26, 2022
Oct 02, 2022
Full Time
By clicking the Apply button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda s Privacy Notice and Terms of Use. I further attest that all information I submit in my employment applicationis true to the best of my knowledge. Job Description As a key member of the Regional RA and Regulatory A&P leadership team, this role is involved in establishing the strategic direction and implementation of regulatory strategies for Takeda products within the EUCAN region. Is a standing member of the EUCAN Leadership Team (ELT); representing EUCAN regulatory affairs personnel for the region ensuring regulatory activities are aligned with the commercial priorities for EUCAN BU and the European Research Centre Leadership Team; to create/support a strong and visible R&D community within Europe. Provides leadership and direction for regulatory activities working closely with internal functional experts within Development, Commercial and Manufacturing organizations. Ensures the development of a strategic regulatory approach in consideration of EUCAN needs/requirements and in partnership with Global RA Strategy; this includes regulatory input to achieve optimal regional considerations for development and life cycle management plans ACCOUNTABILITIES Provides regulatory expertise and ensures appropriate regulatory guidance and support is provided to development teams and established products for Regional consideration. Provides leadership and drives functional aspects of the global regulatory process to ensure timely filing and approval of new products and maintenance of existing products in territories of responsibility in accordance with business objectives. Collaborates with senior management to provide planning, development and implementation of appropriate regulatory strategies to ensure ongoing compliance with regulatory requirements within the Region Directly manages Local Operating Company (LOCs) Region support group that provides day to day support and expertise between the Global Regulatory functions and the LOC regulatory personnel Chairs Regional Regulatory Leadership Team which is comprised of Regional Team Leads and the Regional LOC RA Heads Responsible for ensuring there is sufficient regulatory input into the global development plans and strategies for all countries within the Region. Strong understanding of the commercial dynamics of the Region as it relates and impacts regulatory strategies and issues. Has experience in working closely with Region commercial personnel Serves as primary regulatory liaison for all territories of responsibility to other Takeda entities. Provides insight and continual research into future direction of EU Regulatory Affairs and how to best prepare for emerging trends, regulations and changes, enabling Takeda to take a proactive approach and proactive planning to future business requirements. Represents EUCAN RA in strategic planning with Region Business Unit leadership Technical/Functional expertise Master s or other advanced degree (MD, PhD, PharmD) preferred. Demonstration of successful submissions/management for EUCAN, as well as fundamental knowledge of regulatory processes outside of EUCAN region. Outstanding interpersonal, communication and organizational skills. Proven track record in managing global, cross-functional projects or organizations Extensive experience in managing regulatory interactions with Regional Health Authorities (HAs) including key EMA, and MHRA meetings as well as preparing the global team for these Health Authority interactions. Previous experience serving on industry external committees (DIA, PhRMA) a plus. Knowledge of the drug development process, with focus on CTA and MAA processes. Experience with biologics and small molecule products. Demonstrated ability to interface with relevant regulatory authorities beyond standard HA meetings. Excellent regulatory judgment and knowledge of global regulatory guidelines as they relate to the overall global regulatory strategy. Results driven and team-oriented with the ability to influence outcomes. Ability to function at a high level of independence within a highly matrixed environment. Excellent project and time management skills to drive multiple complex projects simultaneously and able to innovate, analyze and solve problems with minimal supervision and strong attention to detail. Demonstrated ability to lead and motivate a global staff. Track record of successful leadership, management, and development of large, multi-disciplinary globally dispersed teams. Excellent written and oral communication skills. Previous experience leading a medium to large organization and influencing senior-level management and key stakeholders is a plus Proven track record of leading and driving business process transformation and organizational culture change as well as delivering on programs with complex business deliverables Locations Zurich, Switzerland Worker Type Employee Worker Sub-Type Regular Time Type Full time

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