Senior Manager, Regulatory Lead

Join Takeda as a Senior Manager, Regulatory Lead based in Boston, Suffolk County, where you'll shape regulatory strategy and drive compliance excellence for a leading pharmaceutical organization committed to patients and innovation.

About the Role

This full-time position offers a leadership opportunity to oversee regulatory affairs initiatives and ensure regulatory compliance across key programs. You'll report directly to senior leadership, serving as the primary regulatory guide for your department's operations, strategy execution, and cross-functional partnerships.

What You'll Do

• Direct regulatory strategy development, submission planning, and approval pathway optimization for pharmaceutical products and development programs
• Lead and mentor regulatory professionals, fostering a culture of compliance and continuous improvement within your team
• Manage regulatory submissions, dossiers, and documentation packages to ensure accuracy, completeness, and alignment with global regulatory requirements
• Serve as subject-matter expert and liaison with regulatory agencies, maintaining strong relationships and coordinating communications on technical and strategic matters
• Oversee compliance with FDA regulations, international regulatory codes, and industry standards applicable to the organization's product portfolio
• Collaborate with clinical, commercial, quality, and medical affairs teams to integrate regulatory considerations into program planning and execution
• Monitor regulatory landscape changes and emerging requirements, providing recommendations to adapt processes and maintain operational readiness
• Support business development initiatives by conducting regulatory risk assessments and gap analyses on potential acquisitions or partnerships

What We're Looking For

• 15+ years of experience in pharmaceutical regulatory affairs, with 5+ years in a senior leadership or management role
• Deep knowledge of FDA regulations, ICH guidelines, and international regulatory frameworks governing drug development and commercialization
• Proven track record leading cross-functional teams, mentoring professionals, and driving organizational change
• Demonstrated expertise in regulatory submission preparation, strategy development, and agency engagement
• Master's degree in pharmacy, life sciences, chemistry, or related field; additional regulatory certifications or advanced business credentials a plus
• Strong communication and stakeholder management abilities, with experience presenting to executive leadership and regulatory agencies
• Project management capability and attention to detail in a fast-paced, highly regulated environment

About Takeda

Takeda is a global pharmaceutical leader dedicated to discovering, developing, and delivering medicines and vaccines that transform patients' lives. The company pursues innovation in oncology, gastroenterology, neuroscience, and plasma-derived therapies, maintaining operations across multiple continents and serving patients worldwide.

How to Apply

To apply, complete your application directly on this page, or you'll be redirected to the employer's application platform to finish submitting there.