Head of Global Regulatory Affairs, Oncology

Takeda•Boston, MA

1d•Onsite

About The Position

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.

Requirements

Minimum BS degree; advanced degree (MS, MBA, PhD or MD) preferred
15 + years of industry experience in Regulatory Affairs development with responsibilities for major aspects of strategic planning, implementation and delivery of clinical programs, ideally withing Oncology.
Extensive experience in interacting/negotiating with 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.
Proven track record of leading and driving business process transformation and organizational culture change as well as delivering on programs with complex business deliverables.
Operational experience in pharmaceutical drug development with significant direct exposure to clinical development.
Track record of successful leadership, management, and development of large, multi-disciplinary globally dispersed teams.
Strong judge of talent with the ability to make tough talent decisions.
Health care business acumen with a comprehensive understanding of the pharmaceutical industry.

Responsibilities

Provide enterprise-level leadership and vision for global regulatory affairs across the full oncology portfolio.
Shape regulatory strategy as a driver of corporate growth, portfolio prioritization, and market access.
Serve as primary advisor to executive leadership.
Full portfolio-level ownership across all oncology assets, with end-to-end accountability from early development through commercialization and lifecycle strategy.
Global accountabilities with Indirect ownership over all countries where oncology operates.
Define enterprise-wide regulatory strategy, including policy, 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 product inception to end of lifecycle with interaction with global Health Authorities.
Global Regulatory Leads represent GRA 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 in all regions.
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 of global business priorities.
Identify regulatory requirements and trends across therapeutic areas of responsibility, and provide regulatory guidance, and expertise to global program team (GPT), oncology governance bodies and Takeda governance bodies in these areas.
Responsible for global regulatory development plans/strategies for all oncology projects, with scope (consolidated across US, JPN, China, EU and International) including ensuring clinical trial requirements for global product approval are met.