US Lead, Global Regulatory Policy & Innovation

03 Jan, 2022


US Lead, Global Regulatory Policy & Innovation

Takeda Pharmaceuticals

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Job Description

About the role:

Our vision is to be a forward-looking, world-class R&D organization that unlocks innovation and delivers transformative therapies to patients.

Join Takeda as a US Lead (Director), Global Regulatory Policy & Innovation where you will provide leadership for regulatory interactions on policy and advocacy issues. As part of the Global Regulatory Policy & Innovation Team, you will report to the Head of Global Regulatory Policy & Innovation and contribute to Takeda’s mission by building relationships with key regulatory decision makers globally.

How you will contribute:

  • Represent Global Regulatory Policy & Innovation and GRA on US-focused internal and external forums/networks as assigned. Provide impactful summaries and strategic advice, back to the business, regarding assigned activities. Provide leadership to influence the regulatory environment to meet business needs.
  • Lead GRA and R&D participation in US regional committees to drive effective networking and representation to ensure a one voice policy.
  • With GRPI colleagues, develop and execute a US regulatory intelligence strategy. Remain current on 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.
  • Contribute and lead, where appropriate, to the development and implementation of appropriate systems, processes and standards within GRPI, US GRPI, GRA and across Takeda as assigned.
  • Work closely and partner with GRPI 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.
  • Support and be accountable for the management and maintenance of special projects such as US 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, 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. Present to senior management as relevant.
  • Responsible for demonstrating Takeda Leadership Behaviors.

What you bring to Takeda:

  • BS – PhD, JD, MD, or equivalent strongly preferred. Proven track record working with a major regulatory agency, specific experience in government affairs or policy is also desired.
  • 10 years of pharmaceutical industry experience. This is inclusive of 8 years regulatory experience or a combination of 10 years regulatory and/or related experience in both development and post-marketing phases.
  • Strong knowledge of regulations and guidance governing drugs and biologics in all phases of development, including post-marketing, in the US, with an understanding of basic regulatory requirements in other global markets (Japan, EU) and emerging markets. Sound knowledge of intelligence tools and methods.
  • Understand and interpret 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.
  • 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 CROs and/or contractors a plus

What Takeda can offer you:

  • Comprehensive Healthcare: Medical, Dental, and Vision
  • Financial Planning & Stability: 401(k) with company match and Annual Retirement Contribution Plan
  • 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 and company match of charitable contributions
  • Family Planning Support
  • Flexible Work Paths
  • Tuition reimbursement

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.

Absent an approved religious or medical reason, all US office-based and lab-based Takeda employees who work fully on-site or in a hybrid model (as determined by Takeda) must be fully vaccinated to work at a Takeda site or to engage with Takeda colleagues or anyone else on behalf of Takeda. US field-based employees must be fully vaccinated as a condition of employment, absent an approved religious or medical reason. US employees who work at a Takeda manufacturing facility, and those who work at a BioLife center or BioLife lab, may be subject to different guidelines. If you are contacted by a Takeda recruiter about your job application, we encourage you to seek more information on the applicable guidelines for the Business Unit/Function to which you have applied.

Base Salary Range: $185,000.00 – $215,000.00, based on candidate professional experience level. Employees may also be eligible for Short Term and Long-Term Incentive benefits. Employees are eligible to participate in Medical, Dental, Vision, Life Insurance, 401(k), Charitable Contribution Match, Holidays, Personal Days & Vacation, Student Loan Repayment Program and Paid Volunteer Time Off.


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.

Learn more here

Job posted: 2022-01-03