Director, Global Regulatory Affairs CMC

Role Summary

Lead the regulatory CMC strategy and execution for assigned products within Takeda's Global Regulatory Affairs organization. Represent Regulatory, Pharmaceutical Development, and Commercial teams across clinical development and lifecycle, and mentor other GRA CMC members. The role requires expert knowledge of GRA CMC regulations and the ability to drive global submissions and ensure regulatory compliance. This role operates within the GRA CMC and Devices organization and collaborates across a matrix to deliver regulatory success. Location: Boston, MA.

Responsibilities

• Independently develops the regulatory CMC strategy and leads the execution of regulatory CMC investigational, registration and post-approval strategies for assigned product(s) as the GRA CMC Product Lead.
• Represents and contributes to Regulatory, Pharmaceutical Development, and Commercial project teams throughout clinical development and the commercial lifecycle.
• Demonstrate a high level of leadership and expert understanding of GRA CMC regulations and guidelines.
• Apply and adapt this understanding to projects to enhance probability of regulatory success and regulatory compliance. Ability to draw from prior experience, precedents and other regulatory intelligence beyond regulations.
• Strong analytical or process understanding that enables the development of robust and accurate submissions.
• Develops constructive relationships with and proactively communicates issues to key internal and external colleagues, including Alliance Partners.
• Successfully communicates and negotiates with Health Authorities – directly and indirectly.
• Able to apply expert GRA CMC knowledge to address and overcome challenges that arise during development and commercialization.
• Acts as mentor / coach to other GRA CMC members.
• Develops, executes and oversees the preparation of major global registrational submissions.
• Guides the team to define and drive strategy for CMC regulatory dossier content and reviews this content for conformance with established requirements; understands the overall product strategy and anticipates future challenges.
• Represents Takeda GRA CMC in Health Authority meetings and drives preparation activities for meetings with Health Authorities on CMC-related matters.
• Provides guidance to teams on administrative procedural topics while interacting with International Health Authorities as required.
• Fosters constructive working relationships when interacting with internal and/or external colleagues.
• Provides strategic input into change control evaluation as required.
• As a GRA CMC member, ensures and/or enhances regulatory compliance.
• Ensures project team colleagues, line management, and key stakeholders are apprised of developments that may impact regulatory success, exercising sound judgement and communicating in a professional and timely manner.
• Reviews, provides regulatory CMC input and approves – as needed – technical protocols, reports, etc. to ensure alignment with global regulatory requirements and standards.
• When in a GRA CMC Product Team lead role, prepares and maintains relevant regulatory documentation (e.g., technical regulatory strategy documents, storyboards, risk assessments, etc.) and provides tactical regulatory guidance to product teams in line with global regulatory strategies. Accountable for development and/or commercial products approvals and meeting targets for projects/products within respective modalities.
• Proactively identifies regulatory CMC risks, ensuring timely communication with line management.
• Leads assigned global regulatory submissions (e.g., Core Dossiers, INDs, CTAs, BLAs, MAAs, Variations, etc.) through product lifecycle.
• Provides global regulatory input and support on product-compliance related activities including change controls, deviations, and investigations.
• Works effectively across a complex matrix environment in GRA with GRLs, CMC RA project leads and other GRA sub-functions (e.g., Growth & Emerging Markets, Strategy, Labelling, etc.) to ensure effective strategies are implemented and project execution is on target.
• Supports development of strategies, tools, and trainings to further the GRA CMC roadmap.
• Proactively communicates CMC regulatory strategies, key issues and risks through assigned programs / products development activities and LCM in adequate and timely manner to cross-functional programs/ products teams and management level within GRA CMC, GRA, PS, GMS and QA - as appropriate.

Qualifications

• 10+ years of overall biopharmaceutical/device industry experience with 8+ years pharmaceutical Regulatory CMC and/or devices experience, while leading major submissions during LCM, development – including preparation of NDA/BLA/MAA.
• Equivalent industry experience in Pharmaceutical Development, Analytical Development, Production, Quality Assurance can 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 mindset with attention to detail; ability to assess alternative approaches.
• Base regulatory strategy recommendations on precedents and other regulatory intelligence as well as regulations and guidelines.
• Able to deal with issues of critical importance with minimal oversight.
• Exercises good judgment in elevating and communicating actual or potential issues to line management.
• Applies direction taken by the company.
• Demonstrates emerging leadership, problem-solving ability, flexibility and values teamwork.
• Intentionally promotes an inclusive culture.
• Applies given prioritization framework with limited support.
• Excellent written and oral communication skills.

Skills

• Leadership and mentoring within GRA CMC
• Regulatory strategy development and global submissions
• Cross-functional collaboration across Regulatory, Development, Commercial, QA, and external partners
• Stakeholder management and communication with Health Authorities
• Regulatory intelligence, risk assessment, and proactive issue escalation

Education

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