Senior Director Global Regulatory Affairs Strategy Lead

5 days ago

San Francisco, California, United States Daiichi Sankyo, Inc. Full time
Job Title: Senior Director Global Regulatory Affairs Strategy

About Daiichi Sankyo, Inc.

Daiichi Sankyo, Inc. is a leading pharmaceutical company dedicated to improving standards of care and addressing unmet medical needs globally. With a rich legacy of innovation and a robust pipeline of promising new medicines, we are committed to delivering innovative therapies to patients worldwide.

Job Summary:

This Senior Director position is responsible for providing strategic leadership and oversight for global regulatory submissions in Oncology across the US, EU, Japan, China, and other regions. The successful candidate will ensure alignment of regulatory strategies within the department and adherence to therapeutic area direction and corporate objectives.

Key Responsibilities:

  • Lead a multidisciplinary Global Regulatory Team (GRT) to develop global regulatory strategy and plans for assigned global projects, ensuring appropriateness throughout the product's lifecycle and across different indications.
  • Represent Daiichi Sankyo's regulatory group in internal and external development project meetings, providing guidance to peers and cross-functional team members regarding strategic regulatory issues.
  • Interface with clinical and pre-clinical groups, Regulatory CMC, and other appropriate groups within the company as needed, reviewing and interpreting regulatory guidelines, regulatory precedence, and competitive landscape with respect to impact on development programs.

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.
  • Travel - Ability to travel up to 20% In-house office position that may require occasional travel (global).

Equal Opportunity Employer:

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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