Director, Global Regulatory Lead, Plasma-Derived Therapies R&D
Location: Boston, Massachusetts
About the Role: The Plasma-Derived Therapies (PDT) R&D Organization at Takeda is dedicated to developing innovative plasma-derived therapies for patients with immunologic, hematologic, and complex diseases. As the Global Regulatory Lead, you will be responsible for the regulatory strategy and lifecycle management across the PDT product portfolio. You will lead global regulatory activities, ensure compliance with applicable regulations, and act as the key liaison with the US FDA and other health authorities globally.
Key Responsibilities:
Serve as the global regulatory lead for assigned projects, leading the Global Regulatory Team (GRT).
Develop, implement, and maintain global regulatory strategies.
Collaborate with regional counterparts to ensure critical regulatory deliverables are met globally.
Lead the preparation of regulatory submissions (e.g., BLAs, INDs, CTAs, MAAs) and related documentation.
Manage all FDA health authority interactions for assigned programs.
Keep project teams and leadership informed of regulatory developments and risks.
Utilize tools like InterACT and Dragonfly for regulatory status reporting.
Lead regulatory assessments for due diligence activities.
Technical/Functional Expertise:
In-depth knowledge of global regulatory requirements for drugs and biologics.
Experience leading interactions with the US FDA and supporting international health authority engagements.
Proven ability to develop and execute innovative regulatory strategies.
Extensive experience with regulatory submissions and rare disease product development.
Leadership and Influence:
Demonstrated ability to lead and mentor in a matrix environment.
Global mindset with strong cross-functional collaboration skills.
Effective in influencing and negotiating regulatory pathways and decisions.
Champions diversity, equity, and inclusion within the team and organization.
Decision-Making and Autonomy:
Makes decisive, data-driven decisions even under ambiguity.
Proactively identifies risks and implements mitigation strategies.
Balances stakeholder feedback while ensuring timely execution.
Interaction and Communication:
Strong written and verbal communication, negotiation, and presentation skills.
Engages and influences internal and external stakeholders effectively.
Builds internal networks to drive alignment and execution.
Innovation and Complexity:
Continuously challenges the status quo and implements innovative solutions.
Navigates complexity across commercial, operational, and strategic areas.
Provides clarity and accountability within a highly matrixed environment.
Minimum Requirements/Qualifications:
Bachelor’s degree (BSc preferred); advanced degree a plus.
Minimum of 10 years in the pharmaceutical industry, including 8 years in regulatory strategy roles.
At least 5 years of direct regulatory strategy and/or regulatory submission experience.
Experience with plasma or biologics products preferred.
Strong FDA interaction and regulatory submission experience.
Strong leadership, collaboration, and communication skills.
Workplace Type:
Hybrid (in alignment with Takeda’s Hybrid and Remote Work Policy)
Compensation Summary:
U.S. Base Salary Range: $174,500.00 - $274,230.00
Eligible for short-term and long-term incentives.
Comprehensive benefits package including medical, dental, vision insurance, 401(k) plan, paid vacation, and volunteer time off.
About Takeda: Takeda is a global, patient-focused company dedicated to delivering Better Health and a Brighter Future through life-changing treatments. Certified as a Global Top Employer, Takeda fosters an inclusive, collaborative workplace where innovation and excellence thrive.
EEO Statement: Takeda is committed to creating a diverse workforce and provides equal employment opportunities without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, or veteran status.
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