| Are you looking for a patient-focused, innovation-driven company that will inspire you and empower you to shine? Join us as a Senior Director, Global Regulatory Intelligence & Policy in our Cambridge, MA office. At Takeda, we are transforming the pharmaceutical industry through our R&D-driven market leadership and being a values-led company. To do this, we empower our people to realize their potential through life-changing work. Certified as a Global Top Employer, we offer stimulating careers, encourage innovation, and strive for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our global teams are united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world. Here, you will be a vital contributor to our inspiring, bold mission. As a Senior Director, Global Regulatory Intelligence & Policy working on the Global Regulatory Intelligence & Policy team, you will be empowered to provide leadership for regulatory interactions on policy and advocacy issues. In this role, you will contribute to Takeda’s mission by building relationships with key regulatory decision makers globally. A typical day will include: OBJECTIVE: - Global regulatory intelligence contact for key stakeholders including therapeutic areas and regional teams as determined in collaboration with regional EU, US, Japanese and EM Regulatory Intelligence and Policy colleagues.
- Provide guidance for company relationships with other regulators and decision makers to further expand these relationships.
- Leads Global Regulatory Intelligence & Policy (GRIP) to create vision for Regulatory Intelligence working collaboratively with regional colleagues with delivery of a work plan to meet that vision. Also works closely with the Regional Policy leads to drive success at the regional regulatory interface.
- With GRIP colleagues, define and oversee the standardization and implementation of systems/processes to monitor the regulatory environment for changes that may have an impact on Takeda’s products and goals. As such bring functional excellence to Global Regulatory Policy & Intelligence. Drive best practices and excellence in execution within the department and cross-functionally.
- Utilizes his / her experience to oversee the strategic assessment of external regulatory changes globally and, to work with subject matter experts within the Company, to drive or support the decision-making process to understand and prioritise the regulatory risks & opportunities globally: the internal impact analyses, development of strategies/ positions and drive for appropriate action(s) relevant to Takeda's Therapeutic Areas of focus and development projects.
ACCOUNTABILITIES: - Represent Global Regulatory Policy & Intelligence and GRA on internal and external forums/networks as assigned. Provides impactful summaries and strategic advice, back to the business, regarding assigned internal/external activities. Provides leadership to influence the regulatory environment to meet business needs.
- Oversee GRA participation in regional committees to drive effective networking and representation to ensure a one voice policy.
- Develop and execute a regulatory intelligence strategy. Keep abreast of internal and external changes, trends, developments and other dynamics relevant to the regulatory environment that may have impact to Takeda’s regulatory and access strategies and propose action plan.
- Oversee the development and implementation of appropriate systems, processes and standards within GRIP, GRA and across Takeda as assigned.
- With GRIP colleagues, lead the development of a global policy and advocacy strategy for GRIP. Work closely and partner with GRIP colleagues and subject matter experts to plan and execute regulatory advocacy positions, strategies and tactics and facilitate engagement with regulators on key topics of interest. This includes to liaise closely with colleagues (R&D, Policy, etc.) leading policy activities in the external environment to ensure regulatory insights and overall alignment on Takeda position.
- Provide oversight for or have primary responsibility for the management and maintenance of special projects such as Global Regulatory Affairs Priority Topic list, position papers, and regulatory issues/trends reports, as assigned.
- Partner with Government/Public Affairs to understand and monitor evolving trends for Access requirements regionally/globally, work with internal stakeholders to identify opportunities/threats and advocate Takeda’s positions externally.
- Maintain consistent oversight of deliverables. Keep GRA management and all internal customers, partners and stakeholders abreast of progress and provide interim updates on ongoing activities and current initiatives. Ensure issues are escalated when needed and encourage resolution at the appropriate level.
- Lead routine and ad hoc meetings within function and cross-functionally.? Presents to senior management as relevant.
- Manages personnel within group to ensure coverage for regional responsibilities; Elevates needs when necessary.
- Responsible for demonstrating Takeda Leadership Behaviors.
SCOPE OF SUPERVISION: - Supervise 1-2 Direct Employees and 2-4 Indirect Employees.
EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS: - BS - Advanced scientific related degree preferred; BA accepted based on experience. Advanced degree preferred.
- A minimum of 15 years pharmaceutical industry experience. This is inclusive of 10 years regulatory experience or a combination of 15 years of regulatory and/or related experience in both development and post-marketing phases.
- Thorough Knowledge of regulations and guidance governing drugs and biologics in all phases of development, including post-marketing, in the US and/or EU (relevant to role), with a good understanding of basic regulatory requirements in emerging markets. Sound knowledge of intelligence tools and methods.
- Understands and interprets complex scientific issues across projects and therapy area(s) of responsibility as it relates to regulatory requirements, regulatory intelligence, policy and strategy for the region. Proven track record working with a major regulatory agency, specific experience in government affairs or policy is also desired.
- Excellent collaboration/relationship building, strong influencing and negotiation skills, integrity and adaptability. Outstanding written and oral communication skills as well as managing and adhering to timelines. Proven success at stakeholder engagement across organizational levels and boundaries.
- Must be strong overall and able to train/develop staff in the area of regulatory intelligence and policy such as understanding broad concepts within regulatory affairs and implications across the organization and globally; proactively identifies regulatory trends and offers risk mitigation strategies.
- Ability to develop regulatory strategy to balance short and long term objectives, and support GRLs/regional regulatory leads to drive teams to make decisions and achieve deliverables within agreed parameters and timescales.
- Must be strong leader, working well with others, within global teams and 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. Able to mentor and develop skills of staff.
- Experience in managing personnel required; experience managing relationships with CROs and/or contractors also preferred.
PHYSICAL DEMANDS: - Manual dexterity required to operate office equipment (i.e. computers, phones, etc.).
- Carrying, handling and reaching for objects.
- Ability to sit or stand for long periods of time while traveling
TRAVEL REQUIREMENTS: - Willingness to travel to various meetings or client sites, including overnight trips. Some international travel may be required.
- Requires approximately 10-30%.
WHAT TAKEDA CAN OFFER YOU: - 401(k) with company match and Annual Retirement Contribution Plan
- Tuition reimbursement Company match of charitable contributions
- Health & Wellness programs including onsite flu shots and health screenings
- Generous time off for vacation and the option to purchase additional vacation days
- Community Outreach Programs
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