US Lead, Global Regulatory Policy & Innovation

at Takeda Pharmaceuticals in Montpelier, Vermont, United States

Job Description

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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 three 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 & Innovation, Oncology, where you will anticipate, assess, and influence US regulatory policy impacting oncology 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 insight and advantages to product teams and business units by partnering on impact assessment of external regulatory changes, anticipating and communicating regulatory trends and evolving policy, , and advising on policy development and advocacy strategies to close gaps between Takeda positions and the FDA regulatory landscape.

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. Lead and provide expertise to US GRPI team initiatives and work collaboratively with regional colleagues with delivery of a work plan to meet that vision. As part of the Global Regulatory Policy and Innovation team, you will report to the US Head, Global Regulatory Policy and Innovation.

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 to the business, regarding assigned internal/external activities.

+ Provide leadership to influence the regulatory environment to meet business needs.

+ Support and 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. 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.

+ 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 in the organization leading policy activities in the external environment to ensure regulatory insights and overall alignment on Takeda position.

+ 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.? Presents to senior management as relevant.

Minimum Requirements/Qualifications:

+ PhD, PharmD, MD, JD, or equivalent preferred. Proven track record working with FDA agency in a policy capacity with a strong preference for history of working with FDA’s Oncology Center of Excellence.

+ At least 5 years relevant professional 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 good understanding of basic regulatory requirements in other global markets (Japan, EU) and emerging markets.

+ 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.

+ 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.

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.

This position is currently classified as “remote” in accordance with Takeda’s Hybrid and Remote Work policy.

Base Salary Range: $160,300 to $229,000, based on candidate professional experience level. Employees may also be eligible for Short-term and Long-Term Incentive benefits as well. Employees are eligible to participate in Medical, Dental, Vision, Life Insurance, 401(k), Charitable Contribution Match, Holidays, Personal Days & Vacation, Tuition Reimbursement Program and Paid Volunteer Time Off.

The final salary offered for this position may take into account a number of factors including, but not limited to, location, skills, education, and experience.

In accordance with the CO Equal Pay Act, Colorado Applicants Are Not Permitted to Apply.


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 ori

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Job Posting: JC248379457

Posted On: Sep 23, 2023

Updated On: Nov 18, 2023

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