Head of Global Regulatory Affairs, Oncology
応募 後で応募 求人ID R0182669 掲載日 06/18/2026 Location:Boston, MassachusettsBy clicking the “Apply” button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda’s Privacy Notice and Terms of Use. I further attest that all information I submit in my employment application is true to the best of my knowledge.
Job Description
About this role:
Join Takeda as a Head of Global Regulatory Affairs – Oncology where you will provide global regulatory oversight for the assigned therapeutic area, focused on non-clinical and clinical aspects of drug development and associated regulations. You will provide asset-level responsibility for both US and EU HA interactions and procedures (including direct reporting lines). As part of the Global Regulatory Affairs team, you will report to the Head of Global Regulatory Affairs and provide core input to Global Program Team(s) throughout development programs.
How you will contribute:
Provideenterprise-level leadership and visionfor global regulatory affairs across the full oncology portfolio. Shape regulatory strategy as adriver of corporate growth, portfolio prioritization, and market access. Serve asprimaryadvisor to executive leadership.
Fullportfolio-level ownership across all oncology assets, with end-to-end accountability from early development through commercialization and lifecycle strategy.Global accountabilities withIndirect ownership over all countries where oncologyoperates.
Define enterprise-wide regulatory strategy, includingpolicy, innovation, and competitive positioning, influencing both internal portfolio decisions and external regulatory environments.
Own global HA engagement strategy, including precedent-setting interactions, escalation-level negotiations, and shaping regulatory expectations.
Provide core input to Global Program Team(s) throughout development programs.
Develop and implement innovative, competitive global regulatory strategies from productinceptionto end of lifecyclewith interaction with globalHealthAuthorities.GlobalRegulatory LeadsrepresentGRA at GPT and lead Global Regulatory Teams (GRTs).
Provide strategic regulatory input to global teams and regional cross functional teams for new product filings and business initiatives.
Responsible for the development of regional regulatory strategies that de-risk and accelerate the registration of innovative and established medicines inallregions.
Flawless execution of global registration strategies that enhance the likelihood of regulatory approval through the pursuit of novel regulatory pathways and continuous sponsor/regulatory dialog in support ofglobalbusiness priorities.
Identifyregulatory requirements and trends across therapeutic areas of responsibility, andprovideregulatory guidance, andexpertiseto globalprogramteam(GPT),oncologygovernancebodiesandTakedagovernance bodiesinthese areas.
Responsible for global regulatory development plans/strategies for alloncologyprojects,withscope (consolidatedacrossUS,JPN,China,EUandInternational) including ensuring clinical trial requirements for global product approval are met.
Preferred Qualifications:
MinimumBS degree; advanced degree (MS, MBA,PhDor MD) preferred with 15+ years of industry experience in Regulatory Affairs development with responsibilities for major aspects of strategic planning,implementationand delivery of clinical programs, ideally withing Oncology.
Extensive experience ininteracting/negotiatingwith US (FDA),EU (EMEA), PMDA (Japan), NMPA (China) and all global Health Authorities.
Senior management experience in Regulatory Affairs or related field, leading a medium to large organization and influencing senior-level management and key stakeholders.
Proventrack recordof leading and driving business process transformation and organizational culture change as well asdelivering onprograms with complex business deliverables.
Operational experience in pharmaceutical drug development with significant direct exposure to clinical development.
Track recordof successful leadership, management, and development of large, multi-disciplinary globally dispersed teams. Strongjudgeof talent with the ability to make tough talent decisions.
Health care business acumen with a comprehensive understanding of the pharmaceutical industry.
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.
For Location:
Boston, MAU.S. Base Salary Range:
$352,000.00 - $484,000.00
The estimated salary range reflects an anticipated range for this position. The actual base salary offered may depend on a variety of factors, including the qualifications of the individual applicant for the position, years of relevant experience, specific and unique skills, level of education attained, certifications or other professional licenses held, and the location in which the applicant lives and/or from which they will be performing the job. The actual base salary offered will be in accordance with state or local minimum wage requirements for the job location.
U.S. based employees may be eligible for short-term and/ or long-term incentives. U.S. based employees may be eligible to participate in medical, dental, vision insurance, a 401(k) plan and company match, short-term and long-term disability coverage, basic life insurance, a tuition reimbursement program, paid volunteer time off, company holidays, and well-being benefits, among others. U.S. based employees are also eligible to receive, per calendar year, up to 80 hours of sick time, and new hires are eligible to accrue up to 120 hours of paid vacation.
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.
Locations
Boston, MAWorker Type
EmployeeWorker Sub-Type
RegularTime Type
Full timeJob Exempt
YesIt is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.