Sr. Director Regulatory Affairs Oncology, EUCAN応募 後で応募 求人ID R0013301 掲載日 10/30/2019 Location:Zurich, Switzerland
SENIOR DIRECTOR REGULATORY AFFAIRS, ONCOLOGY - EUROPE & CANADA (EUCAN)
Oncology Therapeutic Area (TA) Team Lead
Global Regulatory Affairs
Reports To (Position Title):
Vice President, Europe Regulatory Affairs Head
•Defines, develops and leads global and/or regional strategies to maximize regulatory and patient access to enable 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 and/or oversight of marketed product support, while maintaining full compliance with applicable regulatory requirements.
•Provides regulatory expertise for multiple projects or for one highly complex project (e.g. global project with multiple indications and presentations), focused on non-clinical and clinical aspects of drug development and / or post-marketing compliance and life cycle management.
•Provides leadership and development for multiple direct reports for the design and execution of regional and / or global regulatory strategies in collaboration with their regional counterparts, GPT colleagues, and value and access teams.
•Act as deputy to the therapeutic area head and/ or Region regulatory head and/or Marketed Products 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.
•For Europe based roles, 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 Europe Union and European Economic Area for all products in defined therapy area scope. Provides interpretation to the business.
•Oversees global/regional regulatory leads and staff responsible for ensuring global/regional regulatory strategies are written, reviewed and executed according to plan and appropriately capture patient access requirements. May also act as a Regulatory lead. Provide 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/LOC market access and LOC (local operating company) 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 counterparts and IBT to ensure a global and / or 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.
•Directs and oversees multiple projects, generally has global/regional oversight for compounds in a minimum of one disease area. For marketed products; this includes oversight to ensure regulatory compliance (e.g. in registration database) by staff and / or vendor.
•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 global and/ or 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 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; Elevates needs when necessary.
•Presents to senior management.
SCOPE OF SUPERVISION:
6-9 FTEs (depending on which of the teams)
EDUCATION & COMPETENCIES:
•BSc. Advanced scientific related degree preferred; BA accepted based on experience. Advanced degree preferred.
•Extensive pharmaceutical industry experience. This is inclusive of thorough regulatory experience or a solid combination of regulatory and/or related experience in both development and post-marketing phases.
•Thorough knowledge of regulations and guidances governing drugs and biologics in all phases of development in the US and/or 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
•A minimum of 15 years of pharmaceutical industry experience. This is inclusive of 10 years of regulatory experience or combination of 15 years regulatory and/or related experience.
•Requires approximately up to 10-30% travel.