Director Regulatory Affairs

Regulatory Affairs Bothell, Washington South San Francisco, California


Description

Summary: 

The Director of Regulatory Affairs will serve as a Global Regulatory Lead (GRL) for the TUKYSA® (tucatinib) program, with a focus on breast cancer clinical development expansion and life cycle management. The successful candidate will have primary responsibility for developing global regulatory strategies and implementing regulatory activities & submissions in line with TUKYSA® program goals and imperatives. 

Responsibilities:

Provide effective strategic and tactical leadership to support global regulatory plans including: 

  • Develop and implement regulatory strategy and submission plans to support global pivotal clinical trials including health authority meetings, Clinical Trial Applications (CTAs), IND submissions, and supplemental marketing applications
  • Serve as regulatory lead on internal cross-functional teams and communicate regulatory requirements to ensure optimal execution of the regulatory strategy
  • Represent regulatory function on Seagen/Merck collaboration teams
  • Provide regulatory guidance and strategy including identifying and assessing regulatory risks
  • Serve as point of contact with health authorities, as applicable
  • Maintain knowledge of the regulatory landscape to pro-actively assess impact of changes on development plans
  • Monitor and research regulatory intelligence, to bring innovative approaches to the cross‑functional team

Qualifications:

  • Bachelor’s or advanced degree in life sciences
  • Minimum of 8 years of regulatory experience, with at least 6 years in a similar strategic role with an oncology drug, therapeutic biologic or equivalent
  • Knowledge and understanding of global regulations and guidelines
  • Experience in the preparation and submission of regulatory documentation to support all regulatory programs throughout product lifecycle
  • Experience leading a team to prepare and execute health authority interactions
  • Excellent oral and written communication skills for effectively interfacing with all levels of management and departments within the company
  • Strong technical/analytical skills to identify and solve problems independently
  • Proven ability to manage multiple projects, identify and resolve regulatory issues
  • Ability to interpret and understand regulations in the context of the scientific and commercial environment and balance regulatory objectives with business objectives
  • Willingness to work collaboratively and incorporate diverse perspectives into decision-making
  • Self-motivated, assertive, and self-confident with the ability to act with urgency and passion
  • Strong organizational skills in order to maintain a high level of productivity, innovation, and priority-setting
  • Ability to work under pressure, meeting time sensitive deadlines, while maintaining a high level of quality
  • Entrepreneurial, enjoys working in a fast-paced, environment
  • Prior managerial experience is highly desirable
  • Ability to work in Bothell, WA, Seattle, WA or San Francisco, CA locations

As the leading employer in our industry in the Pacific Northwest, Seattle Genetics is proud to offer a competitive total compensation package as well as a comprehensive benefits program designed to support the whole lives of our employees and their families. Benefits include medical, vision and dental coverage, group and supplemental life insurance, 401(k) with company match, tuition reimbursement, relocation assistance and much more. To learn more about Seattle Genetics, please visit www.seattlegenetics.com.

Seattle Genetics is an equal opportunity employer. All qualified applications will receive consideration for employment without regard to race, age, gender identity, sexual orientation, color, religion, sex, marital status, national origin, protected veteran status, disability status, or any other status protected by federal, state, or local law.

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