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Job Description

About the role:

At Takeda, we are a forward-looking, world-class R&D organization that unlocks innovation and delivers transformative therapies to patients. By focusing R&D efforts on four therapeutic areas and other targeted investments, we push the boundaries of what is possible in order to bring life-changing therapies to patients worldwide.

Join Takeda as a US Lead, Global Regulatory Policy and Innovation where you will anticipate, assess, and influence US regulatory policy impacting innovative drug development.   Create and amplify relationship-building opportunities with U.S. regulators and key external stakeholders in the regulatory policy landscape.  Advance Takeda’s reputation as a thought leader and valued partner in prioritized areas of regulatory policy.  Provide strategic and directional insight to product teams and business units and utilize their experience to provide impact assessment of external regulatory changes to Takeda priorities development of strategies/ positions and drive for appropriate action(s) relevant to Takeda's Therapeutic Areas of focus and development projects.

You will also serve as US expert and subject matter lead for regulatory policy and advocacy activities, as assigned, based on global and regional policy priorities.  Collaborate with GRPI team to create global and regional vision for drug development and regulatory environment.   As part of the Global Regulatory & Policy Innovation, you will report to Executive Director & US Head, Global Regulatory Policy & Innovation.

How you will contribute:

• Develop and maintain strong working relationships with GRA Heads of Therapeutic Area Units, Regulatory Affairs, key management team, GRA internal stakeholders, and clinical teams.   
• Provide partnership to support product and pipeline strategy teams, including supporting PTRS Discussions and Engagement, developing precedent research and analysis, and developing external pre-competitive engagements relevant to product pipelines.  
• Utilize experience, industry contacts and external partners / consultants to facilitate and provide strategic guidance to internal regulatory and development teams regarding engaging and building reputation with regulatory agencies.  
• Oversee strategic use of regulatory consultants, maintaining a network of experts and facilitating team engagements in consults.
• Design and conduct regular processes, including internal briefings, to maintain internal awareness and understanding on external regulatory developments, and utilize experience to oversee the strategic assessment of external regulatory changes on internal pipeline. 
• With internal SMEs, identify key region-focused regulatory policy priorities directly relevant to internal pipeline development and build external advocacy strategy to target significant change. 
• Coordinate and manage Takeda engagement within trade association, PhRMA, provide direction for Takeda SMEs, and communicate activities and intelligence to internal stakeholders. 
• Identify and negotiate external opportunities that bridge external policy priorities with internal product development, including CPath, NORD, Charles Forum, and other similar forums. Support, coordinate and lead Takeda SMEs in engagement within external forums and workshops as appropriate.   
• Work and support the global GRPI team to provide globally-focused and coordinated “one-voice” policy engagement.  
• Identify opportunities to improve GRPI and GRA information management, tracking, metrics, and to simplify workflows through automation and the use of digital tools.  
• Display leadership behaviors within Takeda to build the GRA Community and Culture.  

Minimum Requirements/Qualifications:

• PhD, PharmD, MD, or equivalent strongly preferred.  Proven track record working with FDA and/or regulatory strategy teams in a policy capacity.
• A minimum of 10 years of combined experience in the pharmaceutical industry, FDA law or policy, and/or scientific or regulatory policy.
• Strong knowledge of regulations and guidance governing drugs and biologics in all phases of development, including post-marketing, in the US, with a understanding of basic regulatory requirements in other global markets (Japan, EU) and emerging markets.
• Understands and interprets scientific issues across projects and therapy area(s) of responsibility as it relates to regulatory requirements, policy and strategy for the region.
• 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 communicator, and ability to explain complex regulatory issues, trends, and strategies to a wide range of stakeholders
• 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 managing relationships with contractors a plus.

More about us:

At Takeda, we are transforming patient care through the development of novel specialty pharmaceuticals and best in class patient support programs. Takeda is a patient-focused company that will inspire and empower you to grow through life-changing work.

Certified as a Global Top Employer, Takeda offers stimulating careers, encourages innovation, and strives for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our teams are united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world.

This position is currently classified as "Remote" in accordance with Takeda's Hybrid and Remote Work policy.

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Takeda Compensation and Benefits Summary

We understand compensation is an important factor as you consider the next step in your career. We are committed to equitable pay for all employees, and we strive to be more transparent with our pay practices.

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EEO Statement

Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law.

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