Director, Global Regulatory Lead – Oncology
Location: Boston, Massachusetts, United States
Employment Type: Full-Time | Hybrid
Job Level: Senior Leadership
Travel: Minimal
Industry: Pharmaceuticals | Biotechnology | Regulatory Affairs
Company: Takeda
Job Overview
Takeda is seeking an experienced Director, Global Regulatory Lead – Oncology to drive global regulatory strategy for high-impact oncology programs. This senior leadership role is a critical part of Takeda’s Global Regulatory Affairs (GRA) organization and plays a strategic role across all stages of global drug development.
The successful candidate will lead regulatory strategy and major global submissions for complex oncology assets, including first-in-class and best-in-class therapies such as antibody-drug conjugates (ADCs), biologics, and small molecules. This position offers the opportunity to influence global product development and accelerate patient access to life-changing oncology therapies worldwide.
Key Responsibilities
Lead and execute global regulatory strategies for one or more complex oncology development programs
Serve as Global Regulatory Lead (GRL) on Global Project Teams (GPTs)
Act as the primary regulatory contact with the U.S. FDA for assigned programs
Oversee and ensure timely, high-quality execution of major global submissions, including NDA, BLA, and MAA
Ensure regulatory alignment across all regions, including the U.S., EU, Canada, and Rest of World (ROW)
Lead or contribute to Global Regulatory Teams (GRTs) and cross-functional governance forums
Communicate regulatory risks, opportunities, and milestones to senior leadership and key stakeholders
Monitor evolving global regulatory and access trends to proactively shape regulatory strategies
Contribute to due diligence activities for licensing and business development opportunities
Provide leadership, mentorship, and strategic guidance within the Global Regulatory Affairs organization
Required Qualifications & Experience
Bachelor’s degree in a scientific discipline (required)
Advanced degree (MS, PhD, PharmD, or equivalent) strongly preferred
Minimum 8 years of experience in the pharmaceutical or biotechnology industry, including significant regulatory affairs experience
Strong expertise in global drug development and regulatory requirements
In-depth knowledge of U.S. FDA regulations; experience with EU, Canada, and global markets is highly desirable
Proven experience managing major regulatory filings (NDA, BLA, MAA)
Demonstrated ability to develop and execute global regulatory strategies independently
Strong understanding of complex scientific and clinical data in an oncology setting
Excellent written and verbal communication skills, including senior leadership engagement
Ability to work effectively in global, cross-functional, matrixed teams
Work Model
This role is classified as Hybrid, in alignment with Takeda’s Hybrid and Remote Work Policy.
Compensation & Benefits
Base Salary Range (Boston, MA):
USD $174,500 – $274,230 per year
Compensation is competitive and commensurate with experience, skills, education, and location. Takeda also offers a comprehensive benefits package, which may include:
Short-term and long-term incentive programs
Medical, dental, and vision insurance
401(k) retirement plan with company match
Paid vacation, sick leave, and company holidays
Tuition reimbursement and professional development support
Wellness and employee assistance programs
About Takeda
Takeda is a global, values-driven biopharmaceutical company committed to delivering Better Health and a Brighter Future to patients worldwide. Recognized as a Global Top Employer, Takeda fosters an inclusive, innovative, and collaborative work environment where employees are empowered to grow and make a meaningful impact.
Equal Opportunity Statement
Takeda is an equal opportunity employer and is committed to building a diverse workforce. Employment decisions are made without regard to race, color, religion, sex, sexual orientation, gender identity, age, disability, veteran status, or any other characteristic protected by applicable laws.
Apply now on thepharmadaily.com to explore senior leadership opportunities in global regulatory affairs and oncology.
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