Senior Director Global Regulatory Affairs Strategy

4 weeks ago


San Francisco, California, United States Daiichi Sankyo, Inc. Full time

Global Regulatory Affairs Strategy Role

Daiichi Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally. As a key member of the Daiichi Sankyo team, you will be responsible for providing oversight and formulation of strategy for global regulatory submissions in Oncology in the US, EU, Japan, China, and other regions.

Key Responsibilities:

  • Lead a multidisciplinary Global Regulatory Team (GRT) to develop global regulatory strategy and plans for assigned global projects.
  • Represent Daiichi Sankyo's regulatory group in internal and external development project meetings.
  • Interface with clinical and pre-clinical groups, Regulatory CMC and other appropriate groups within the company as needed.

Qualifications:

  • Bachelor's Degree required.
  • Advanced degree (e.g., Masters, Pharm.D., Ph.D.) in a scientific discipline preferred.
  • 10 or More Years Experience in the pharmaceutical industry.
  • 7 or More Years with direct regulatory affairs experience, including experience in regulatory submissions in Oncology.
  • Managerial experience.
  • Experience with ex-US regulatory authorities.

Daiichi Sankyo, Inc. is an equal opportunity/affirmative action employer. Qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected veteran status, age, or any other characteristic protected by law.



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