Head of CMC Regulatory Strategy for Pharmaceuticals

1 week ago

Cambridge, Massachusetts, United States Takeda Full time

Position Overview

At Takeda, we are committed to pioneering advancements in research and development that lead to transformative therapies for patients. Our focus on four key therapeutic areas, along with targeted investments, allows us to redefine the possibilities in delivering life-altering treatments globally.

As the Senior Director of Regulatory Affairs for CMC Small Molecules, you will be responsible for directing the formulation and implementation of regulatory CMC strategies for development and registration. You will serve as a key member of cross-functional teams throughout the clinical development and commercial lifecycle of assigned products, showcasing your leadership and deep understanding of global regulatory CMC standards.

Your role will involve effective communication and negotiation with international health authorities as needed. You will provide regulatory CMC insights for new business initiatives and actively contribute to the enhancement of business processes.

Key Responsibilities:

  • Independently strategize, execute, and oversee regulatory submissions for assigned compounds across various clinical phases, global marketing applications, and post-approval lifecycle activities.
  • Collaborate with global cross-functional teams, interpreting EMA/FDA/ICH/WHO regulations to ensure compliance within the organization.
  • Lead team members in defining CMC content requirements for regulatory submissions and ensure that this content meets established standards.
  • Contribute to the development and improvement of business processes.
  • Assess new business opportunities and participate in due diligence efforts.
  • Foster constructive relationships with key internal and external stakeholders, including cross-functional colleagues, alliance partners, and health authority representatives.
  • Ensure that project team members and stakeholders are informed of developments that may affect regulatory outcomes, exercising sound judgment in communication.
  • Engage with international health authorities as necessary, representing Takeda in meetings and leading CMC preparation activities.
  • Demonstrate proven experience in liaising with regulatory agencies, particularly in successful interactions related to CMC submissions and product development discussions.
  • Manage and develop staff as required, overseeing their professional growth and project responsibilities.
  • Evaluate change proposals for their regulatory implications and filing requirements.

Qualifications:

  • Bachelor's or advanced degree in a scientific discipline.
  • Over 10 years of experience in pharmaceutical regulatory CMC, including roles as a product lead, with a strong preference for international experience.
  • Demonstrated ability to engage with regulatory agencies and lead in agency interactions and product development meetings.
  • Comprehensive understanding of scientific principles and regulatory CMC requirements pertinent to global drug development and post-market support.
  • Proven capability to provide strategic regulatory guidance to development, registration, and post-market support teams.
  • Adept at addressing critical issues, providing regulatory advice, and making informed decisions in the absence of clear regulatory guidance.
  • Exhibit leadership, problem-solving skills, adaptability, and teamwork.
  • Willingness to travel for meetings, including overnight trips, with an expected travel commitment of 10-30%.

About Takeda:

At Takeda, we are dedicated to transforming patient care through the development of innovative specialty pharmaceuticals and exceptional patient support programs. As a patient-focused organization, we inspire and empower our employees to grow through impactful work.

Recognized as a Global Top Employer, Takeda promotes stimulating careers, encourages innovation, and strives for excellence in all endeavors. We cultivate an inclusive and collaborative work environment, united by our commitment to delivering better health and a brighter future for people worldwide.

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