Regulatory Affairs CMC Director

2 days ago


Lexington, Kentucky, United States Takeda Pharmaceutical Full time

Job Summary:

Takeda Pharmaceutical is seeking a skilled Regulatory Affairs CMC Director to join our team in Lexington, MA. In this role, you will lead the execution of regulatory CMC investigational, registration and/or post-approval strategies for assigned products as GRA CMC Product Lead.

About the Role:

You will independently develop and execute regulatory strategies, communicate with Health Authorities directly and indirectly, and proactively identify regulatory CMC risks. As a line manager, you will provide project and administrative oversight to support team goals, mentor direct reports, and foster a culture of high performance and trust.

Main Responsibilities:

  • Develops, executes, and oversees regulatory submissions preparation per the GRA CMC Product Team CMC strategy.
  • 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.

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 pharmaceutical Regulatory CMC and/or devices experience.
  • 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.

What We Offer:

Takeda offers a competitive salary range of $169,400 - $266,200, depending on qualifications and experience. You may also be eligible for short-term and long-term incentives, medical, dental, vision insurance, a 401(k) plan, and company match.

About Us:

Takeda is a patient-focused company that inspires and empowers employees to grow through life-changing work. We are committed to creating a diverse workforce and providing equal employment opportunities to all employees and applicants without regard to race, color, religion, sex, sexual orientation, gender identity, or other protected characteristics.



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