Director, Global Regulatory Affairs CMC

At Takeda, we are a forward-looking, world-class R&D organization that unlocks innovation and delivers transformational therapies to patients. By focusing R&D efforts on four therapeutic areas and other targeted investments, we push the boundaries of what is possible to bring life-changing therapies to patients worldwide.

About the role

This role is within the Global Regulatory Affairs (GRA) Chemistry Manufacturing & Controls (CMC) and Devices organization. As the GRA CMC Product Lead, you will independently develop the regulatory CMC strategy and lead the execution of regulatory CMC investigational, registration, and post-approval strategies for assigned product(s). Prior experience in leading or playing a major role in preparing the CMC aspects of global registrational submissions of complex drug products or a suite of products is preferred.

• Represent and contribute to Regulatory, Pharmaceutical Development, and Commercial project teams throughout clinical development and the commercial lifecycle.
• Demonstrate leadership and expert understanding of GRA CMC regulations and guidelines, applying this knowledge to enhance regulatory success and compliance.
• Draw from prior experience, precedents, and regulatory intelligence beyond regulations to inform strategies.
• Develop constructive relationships with key internal and external colleagues, including Alliance Partners.
• Communicate and negotiate effectively with Health Authorities—directly and indirectly.
• Act as a mentor and coach to other GRA CMC team members.

Responsibilities

• Develop, execute, and oversee the preparation of major global registrational submissions.
• Guide the team to define and drive strategy for CMC regulatory dossier content and review it for conformance with established requirements.
• Understand the overall product strategy and anticipate future challenges.
• Represent Takeda GRA CMC in Health Authority meetings and drive preparation activities for CMC-related matters.
• Provide guidance on administrative procedural topics when interacting with International Health Authorities.
• Foster constructive working relationships with internal and external colleagues.
• Provide strategic input into change control evaluations.
• Ensure and enhance regulatory compliance, keeping project teams and stakeholders informed of developments that may impact regulatory success.
• Review, provide input, and approve technical protocols, reports, and other documents to ensure alignment with global regulatory requirements.
• Prepare and maintain regulatory documentation (e.g., technical regulatory strategy documents, storyboards, risk assessments) and provide tactical guidance to product teams.
• Accountable for development and commercial product approvals, meeting targets for projects/products within respective modalities.
• Proactively identify regulatory CMC risks and communicate them to line management.
• Lead assigned global regulatory submissions (e.g., Core Dossiers, INDs, CTAs, BLAs, MAAs, Variations) through the product lifecycle.
• Provide global regulatory input and support on product-compliance activities, including change controls, deviations, and investigations.
• Work effectively across a complex matrix environment with GRLs, CMC RA project leads, and other GRA sub-functions to implement effective strategies.
• Support the development of strategies, tools, and trainings to advance the GRA CMC roadmap.
• Proactively communicate CMC regulatory strategies, key issues, and risks to cross-functional teams and management.

Requirements

• BS/BA Degree in a Scientific Discipline; Advanced Degree (M.S., Ph.D., etc.) required.
• 10+ years of overall biopharmaceutical/device industry experience with 8+ years in pharmaceutical Regulatory CMC and/or devices, including leading major submissions during LCM and development (e.g., preparation of NDA/BLA/MAA).
• Equivalent industry experience in Pharmaceutical Development, Analytical Development, Production, or Quality Assurance may be considered.
• Strong understanding of scientific principles and regulatory CMC requirements relevant to global drug development and post-market support.
• Proven ability to understand and communicate regulatory strategy to drug development, registration, and post-market support teams.
• Analytical skills with attention to detail and the ability to assess alternative approaches.
• Base regulatory strategy recommendations on precedents, regulatory intelligence, regulations, and guidelines.
• Ability to handle critical issues with minimal oversight and exercise sound judgment in elevating potential issues to line management.
• Demonstrated leadership, problem-solving ability, flexibility, and commitment to teamwork and an inclusive culture.
• Excellent written and oral communication skills.

Benefits

• Medical, dental, and vision insurance.
• 401(k) plan with company match.
• Short-term and long-term disability coverage.
• Basic life insurance.
• Tuition reimbursement program.
• Paid volunteer time off.
• Company holidays.
• Well-being benefits.
• Up to 80 hours of sick time per calendar year.
• New hires eligible to accrue up to 120 hours of paid vacation.
• Eligibility for short-term and/or long-term incentives.

Pay

For Location: Boston, MA, the U.S. base salary range is $177,000.00 - $278,080.00. The actual base salary offered may depend on qualifications, experience, skills, education, location, and other factors.

Schedule

This position is classified as "hybrid" following Takeda's Hybrid and Remote Work policy.