Director, Global Regulatory Affairs CMC

Role Summary

Director, Global Regulatory Affairs CMC leads regulatory CMC strategies for assigned products within Takeda's GRA CMC organization. Responsible for regulatory submissions, interactions with health authorities, and mentoring GRA CMC team members to ensure regulatory success and compliance across development and lifecycle. Based in Boston, MA.

Responsibilities

• Independently develops and leads execution of regulatory CMC investigational, registration and/or post-approval strategies for assigned products as GRA CMC Product Lead.
• Represents and contributes to Regulatory, Pharmaceutical Development, and Commercial project teams throughout clinical development and commercial lifecycle.
• Demonstrates leadership and expert understanding of GRA CMC regulations and guidelines; applies this to enhance regulatory success and compliance.
• Develops robust, accurate submissions through strong analytical or process understanding.
• Builds constructive relationships with internal and external colleagues, including Alliance Partners, and proactively communicates issues.
• Effectively communicates and negotiates with Health Authorities.
• Applies expert GRA CMC knowledge to address challenges during development and commercialization; mentors GRA CMC members as required.
• Leads regulatory submissions (e.g., Core Dossiers, INDs, CTAs, BLAs, MAAs, Variations) through product lifecycle.
• Prepares and maintains regulatory documentation (e.g., technical regulatory strategy documents, risk assessments) and provides tactical regulatory guidance aligned with global strategies.
• Identifies regulatory CMC risks and communicates with line management; ensures regulatory compliance within the product teams.
• Reviews and approves technical protocols, reports, and related documentation to ensure alignment with global regulatory requirements and standards.
• Works across a complex matrix with GRLs, CMC RA project leads, and other GRA sub-functions to implement strategies and meet project targets.
• Provides strategic input into change control evaluations and supports product-compliance activities including change controls, deviations, and investigations.
• Proactively communicates CMC regulatory strategies, issues, and risks to cross-functional teams and management as appropriate.

Qualifications

• BS/BA Degree in a Scientific Discipline; Advanced Degree (MS, PhD, 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 lifecycle management and development (NDA/NDA/MAA).
• Equivalent industry experience in Pharmaceutical Development, Analytical Development, Production, or Quality Assurance may be considered.
• Understanding of scientific principles and global regulatory CMC requirements for drug development and post-market support.
• Proven ability to communicate regulatory strategy to drug development, registration, and post-market teams.
• Attention to detail, strong analytical and problem-solving abilities, and the ability to assess alternative approaches.
• Good judgment in elevating and communicating issues to line management; ability to work with limited oversight.
• Demonstrated leadership, teamwork, and ability to promote an inclusive culture.
• Excellent written and oral communication skills.

Skills

• Regulatory strategy development and execution for CMC in global contexts
• Regulatory submissions management (Core Dossiers, INDs, CTAs, BLAs, MAAs, Variations)
• Health Authority communications and negotiations
• Cross-functional collaboration in matrix environments
• Change control, deviations, investigations related to product compliance
• Regulatory documentation preparation (strategy documents, risk assessments, etc.)
• Mentoring and coaching of team members
• Strategic thinking, risk assessment, and proactive issue management

Education

• BS/BA Degree in a Scientific Discipline
• Advanced Degree (MS, Ph.D., etc.)