Director, Global Regulatory Lead - Oncology

Job Description

Director, Global Regulatory Lead Oncology – responsible for setting global regulatory strategy and leading major submissions for high‑impact oncology programs.

About the role

• Oversee and execute all regulatory activities of one or multiple complex projects in development.
• Serve as global regulatory lead (GRL) on the global project team (GPT) for individual project(s) of responsibility.
• May lead the global regulatory sub‑team (GRT) for assigned projects.
• Serve as global and/or regional regulatory lead as a member of a GRT.
• Primary FDA contact for projects of responsibility.
• Accountable for all US FDA submissions and approvals of project(s) of responsibility.
• Ensure all submission types (NDA/BLA/MAA) are executed on time with high quality.
• Collaborate with all Takeda regions to ensure a global regulatory strategy is created and executed for all projects within the area of responsibility.
• Communicate developments that may impact regulatory success to project team colleagues, line management, and key stakeholders.
• Influence and lead departmental and cross‑functional task‑forces and initiatives.
• Partner with global market access colleagues to lead interactions with joint regulatory/health agency/HTA bodies on product‑specific value evidence topics, as applicable.
• Develop, author and execute global regulatory strategies for complex projects; may oversee execution.
• Monitor and anticipate trends that impact regulatory and access environments to strengthen product development plans.
• Demonstrate Takeda leadership behaviors.
• Lead regulatory assessment as part of due diligence teams for licensing opportunities.
• Identify and propose solutions to management for any resource gaps for assigned project(s).
• Present to senior management as requested.

Minimum Requirements / Qualifications

• Bachelor’s Degree required; advanced degree in a scientific discipline strongly preferred.
• Minimum of 8 years of pharmaceutical industry experience, inclusive of regulatory and/or related experience.
• Solid working knowledge of drug development process and regulatory requirements; FDA knowledge a must; EU, Canada, ROW knowledge a plus.
• Experience in managing major regulatory filings and contributing to regulatory and/or development strategies.
• Understand and interpret complex scientific issues across multiple projects as it relates to regulatory requirements and strategy.
• Strong oral and written communication, adherence to timelines, negotiation skills, integrity and adaptability.
• Strong skills in regulatory strategy with increasing independence.
• Ability to work well with others and within global teams; effective communication with senior leadership.
• Proactive identification of regulatory issues and provision of creative solutions, including risk‑mitigation strategies.

Location

Boston, MA

Compensation

U.S. base salary range: $177,000.00 – $278,080.00. Actual base salary will be based on qualifications, experience, and location.

Benefits

U.S. based employees may be eligible for medical, dental, vision, 401(k) with company match, short‑term and long‑term disability coverage, basic life insurance, tuition reimbursement, paid volunteer time off, company holidays, and well‑being benefits. Eligible for up to 80 hours of sick time and up to 120 hours of paid vacation for new hires.

EEO Statement

Takeda is proud of 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.

Additional Information

This position is classified as “hybrid” following Takeda’s Hybrid and Remote Work policy.