Senior Regulatory Affairs Director, Global CMC Strategy

2 weeks ago

Lexington, Massachusetts, United States Takeda Pharmaceutical Full time
About the Role:

Takeda Pharmaceutical is seeking a highly skilled Senior Regulatory Affairs Director to lead the development and execution of global CMC regulatory strategies for assigned products. As a key member of the Global Regulatory Affairs CMC team, you will be responsible for ensuring regulatory compliance with global health authorities and developing constructive relationships with internal and external stakeholders.

Key Responsibilities:
  • Regulatory Strategy Development: Develop and lead the execution of regulatory CMC strategies for assigned products, ensuring alignment with global regulatory requirements and standards.
  • Regulatory Compliance: Ensure regulatory compliance with global health authorities, including the development and maintenance of relevant regulatory documentation.
  • Stakeholder Management: Develop and maintain constructive relationships with internal and external stakeholders, including Alliance Partners and Health Authorities.
  • Communication and Negotiation: Communicate and negotiate with Health Authorities directly and indirectly, applying CMC regulatory knowledge to address and overcome challenges.
  • Leadership and Collaboration: Lead and collaborate with cross-functional teams, including Regulatory, Pharmaceutical Development, and Commercial, to ensure effective strategies are implemented and project execution is on target.
Requirements:
  • Education: BS/BA Degree in a Scientific Discipline, Advanced Degree (M.S., Ph.D., etc.) preferred.
  • Experience: 8 years of overall biopharmaceutical/device industry experience with 5 years pharmaceutical Regulatory CMC or Device experience, including experience leading a major variation/amendment, supporting an initial IND/IMPD preparation, or supporting an initial NDA/BLA.
  • Skills and Qualifications: 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, and ability to analyze issues with attention to detail.
About Takeda Pharmaceutical:

Takeda Pharmaceutical is a patient-focused company that is transforming patient care through the development of novel specialty pharmaceuticals and best-in-class patient support programs. We are committed to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law.

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