Regulatory Affairs Director for Small Molecules

5 days ago


Boston, Massachusetts, United States Takeda Pharmaceutical Full time

Takeda Pharmaceutical is a leading global biopharmaceutical company driven by our commitment to patients, customers and employees. We strive to foster an inclusive and collaborative work environment that inspires innovation and excellence in everything we do.

We are currently seeking a highly skilled Regulatory Affairs Director for our Small Molecules team. In this role, you will be responsible for overseeing the development and execution of regulatory strategies for our CMC (Chemistry Manufacturing and Controls) development and registration activities.

Key responsibilities include:

  • Leading cross-functional teams to ensure compliance with EMA/FDA/ICH/WHO/Global regulations
  • Defining CMC content requirements for regulatory submissions and reviewing content for conformance with established requirements
  • Developing and maintaining constructive relationships with key internal and external stakeholders
  • Representing Takeda in Health Authority meetings and leading CMC preparation activities

The ideal candidate will have:

  • 10+ years of pharmaceutical regulatory experience, including experience as an RA CMC product lead
  • Significant Small Molecule experience
  • Proven ability to liaise with Regulatory Agencies
  • Strong leadership and problem-solving skills

In return, Takeda offers a competitive salary range of $169,400 - $266,200 per year, depending on qualifications and experience. You will also be eligible for a comprehensive benefits package, including medical, dental, vision insurance, a 401(k) plan, and paid time off.



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