Senior Director, EUCAN Regulatory Affairs Team Lead, Oncology

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Job Description

Objectives

• Defines, develops and leads (together with direct reports) regional regulatory strategies to maximize regulatory approvals and patient access to meaningful medicines in alignment with program objectives.
• Effectively communicates objective assessments of the likelihood of success of these regulatory strategies. Provides strategic and tactical advice and guidance to teams to achieve timely and efficient conduct of development programs while maintaining full compliance with applicable regulatory requirements.
• Provides regional regulatory expertise for projects within the therapeutic area.
• Provides leadership and development for multiple direct reports for the design and execution of regional regulatory strategies in collaboration with their regional counterparts, GPT colleagues, and value and access teams.
• Act as deputy to the Region regulatory head, attending internal or external leadership team meetings, as appropriate.
• Provides direction to senior leadership and teams on emerging trends, regulations and changes, with emphasis on those related to therapeutic areas and/ or region of responsibility enabling proactive approach and planning to future business requirements.
• Manages and oversees interactions with EMA and national health authorities (and HTAs jointly with value and access team in context of parallel consultation) in the European Region for products within their responsibility.

Accountabilities

• Oversees regional regulatory leads and staff responsible for ensuring regional regulatory strategies are written, reviewed and executed according to plan . May also act as a Regulatory lead. Provide regional strategic and tactical advice and guidance to allow the timely and efficient conduct of development programs, while maintaining full compliance with applicable regulatory requirements.
• Partner with the regional market access and LOC RA colleagues to define the strategy for, and to lead and oversee joint interactions with regional and national regulatory/health agency/HTA bodies on value and evidence topics and to support health authority decision making. Collaborate with EUCAN on value and evidence generation and relative effectiveness topics to support patient access.
• Collaborates with Takeda global and regional counterparts and Integrated Franchise Team to ensure the regional regulatory strategy is created and executed upon for all projects within scope of responsibility. Identifies regulatory requirements and trends and provides regulatory guidance, and expertise to global project team and/or higher governance bodies in these areas.
• Oversees and accountable for working with other RA functions and/or vendor to ensure that regulatory submissions and approvals are achieved on schedule within area of responsibility. Understands importance of regulatory documents for value and access discussions and partners with access functions to support access applications.
• In collaboration with global colleagues, works to resolve regional critical conflicts in global regulatory strategies and oversee critical deliverables outside of region as agreed within the global regulatory strategy. Approves regional regulatory strategies and authors for more complex regulatory strategies as needed; oversee execution, generally delegates to staff and / or vendor.
• Supervises multiple direct reports. Manages, trains and provides oversight for staff day-to-day activities.
• Leads critical interactions/meetings with senior representatives of appropriate health authorities; delegates to staff, as appropriate, for other health authority interactions.
• Lead regulatory reviewer in regional due diligence for licensing opportunities.
• Proactively builds/strengthens external stakeholder (Regulatory Agency, external experts, industry organizations, etc) contacts/influence to achieve Takeda strategic goals and objectives.
• Identifies regulatory requirements and trends across therapeutic area(s) of responsibility, and provides regulatory guidance, and expertise to global development team and/or higher governance bodies in these areas.
• Manages personnel within group to ensure coverage for project and therapy area(s) responsibilities;
• Presents regional strategies to senior management as applicable.

EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS:

• BSc. Advanced scientific related degree preferred; BA accepted based on experience. Advanced degree preferred.
• 15+ y experience in Regulatory or Industry setting
• Thorough knowledge of regulations and guidance governing drugs and biologics in all phases of development in the EU (relevant to role), with a good understanding of basic regulatory requirements in emerging markets. Understanding of evidence requirements beyond the regulators (e.g. HTA bodies).
• Solid understanding and ability to interpret complex scientific issues across projects and therapy area(s) of responsibility as it relates to regulatory requirements and strategy.
• Preferred experience in managing multiple filings; or managing multiple programs in closely related development area; global involvement also preferred. Must be able to provide guidance in interpreting regulatory regulations and guidelines. Strong leadership, communication (written and verbal), and management skills are required.
• Excellent written, communication, project management and presentation skills (articulate and persuasive). Pro-active, energetic, self-assured professional with high personal integrity and ability to develop good interpersonal relationships
• Analytical, strategic thinker with proven leadership ability that demonstrates professionalism and establishes respect with excellent people management skills. Demonstrated ability to develop others in the area of regulatory strategy, including as understanding broad concepts within regulatory affairs and implications across the organization and globally; proactively identifies regulatory issues; offering creative solutions and strategies, including risk mitigation strategies.
• Ability to influence others, at all levels of the organization, without direct hierarchal authority, and affect change across organizational boundaries. Ability to collaborate effective with peers, within global teams and in communicating with senior leadership.
• Must be strong leader that creates vision for group. Inspires and motivates group. Takes stand on important issues in productive, respectful way.
• Preferred experience in managing multiple personnel for multiple years as well as experience managing relationships with CROs and/or contractors

Locations

Zurich, Switzerland

Worker Type

Employee

Worker Sub-Type

Regular

Time Type

Full time