Director, Global Regulatory Intelligence & Policy
Are you looking for a patient-focused company that will inspire you and support your career? If so, be empowered to take charge of your future at Takeda. Join us as a Director, Global Regulatory Intelligence & Policy in our Cambridge office.
Here, everyone matters and you will be a vital contributor to our inspiring, bold mission. As a Director, Global Regulatory Intelligence & Policy working on the Research and Development team, you will be empowered to 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 on complex issues to meet business needs. A typical will include:
- Global regulatory intelligence contact for key stakeholders including therapeutic areas and regional teams as determined in collaboration with regional EU, US, Japanese and EM Reg Intel colleagues.
- Support regulatory interactions on policy and advocacy issues externally, including building relationships with key regulatory decision makers and industry networks globally. Provide guidance for company relationships with mature regulators and decision makers to further expand these relationships.
- Leads within 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 GRIP. Develop and 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.
- 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 on complex issues 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 Regulatory Intelligence strategy. Keep abreast of internal and external changes, trends, developments and other dynamics relevant to the regulatory environment that may impact Takeda s regulatory strategy and access strategies and propose/lead the execution of an action plan.
- Play a key role in the development and implementation of appropriate systems, processes and standards within GRIP, GRA and across Takeda as assigned.
- Contribute to the development of a global regulatory policy and advocacy strategy for GRIP. Work closely and partner with GRIP colleagues and a number of subject matter experts to plan and execute global regulatory advocacy positions, strategies and tactics and facilitate engagement with regulators on key complex 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.
- Contribute to or has 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 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 across the company as relevant.
- Staff senior management across the company (e.g. R&D, USBU) for external meetings related to regulatory issues.
- Manages personnel, either directly or indirectly, within group to ensure coverage for regional responsibilities; Elevates needs when necessary.
- Responsible for demonstrating Takeda Leadership Behaviors.
EDUCATION, EXPERIENCE AND SKILLS:
- BSc. Advanced scientific related degree preferred; BA accepted based on experience. Advanced degree preferred
- A minimum of 10 years pharmaceutical industry or related regulatory experience (e.g, health authority). Some direct project/asset team experience in regulatory affairs is preferred. This is inclusive of 8 years regulatory experience or a combination of 10 years of regulatory and/or related experience in both development and post-marketing phases.
- Deep understanding of regulations and guidances 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 strategy such as understanding broad concepts within regulatory affairs and implications across the organization and globally; proactively identifies regulatory issues; offers creative solutions and strategies, including risk mitigation strategies.
- Ability to develop regulatory strategy to balance short and long-term objectives, and drive teams to make decisions and achieve deliverables within agreed parameters and timescales
- Generally strong in 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 or major cross functional projects required; experience managing relationships with CROs, external partners and/or contractors also preferred.
- 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
Empowering Our People to Shine
Learn more at takedajobs.com.
No Phone Calls or Recruiters Please.