US Lead, Global Regulatory Policy and Innovation Expert

8 hours ago

Washington, Washington, D.C., United States Takeda Pharmaceutical Full time
About the Role

Takeda Pharmaceutical is seeking a highly skilled and experienced professional to fill the position of US Lead, Global Regulatory Policy and Innovation. As a key member of our Global Regulatory & Policy Innovation team, you will play a critical role in shaping our regulatory strategy and influencing US regulatory policy.

Key Responsibilities
  • Develop and maintain strong working relationships with GRA Heads of Therapeutic Area Units, Regulatory Affairs, key management team, GRA internal stakeholders, and clinical teams.
  • Provide strategic guidance to internal regulatory and development teams regarding engaging and building reputation with regulatory agencies.
  • Oversee strategic use of regulatory consultants, maintaining a network of experts and facilitating team engagements in consults.
  • Design and conduct regular processes, including internal briefings, to maintain internal awareness and understanding on external regulatory developments.
  • Identify key region-focused regulatory policy priorities directly relevant to internal pipeline development and build external advocacy strategy to target significant change.
Requirements
  • PhD, PharmD, MD, or equivalent strongly preferred.
  • Proven track record working with FDA and/or regulatory strategy teams in a policy capacity.
  • A minimum of 10 years of combined experience in the pharmaceutical industry, FDA law or policy, and/or scientific or regulatory policy.
  • Strong knowledge of regulations and guidance governing drugs and biologics in all phases of development, including post-marketing, in the US, with a understanding of basic regulatory requirements in other global markets (Japan, EU) and emerging markets.
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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