Senior Director Regulatory CMC at Seagen in Bothell, Washington

Posted in Executive 5 days ago.

Type: Full Time





Job Description:

Summary:

Now is the time to explore Seagen for your next career move in the vibrant west coast cities of Seattle and San Francisco. We are currently seeking a Senior Director of Regulatory CMC located at either our South San Francisco, CA site or our corporate headquarters just north of Seattle, WA. At Seagen, you have the opportunity to make a meaningful difference in cancer patients' lives by working together in a culture of innovation, scientific excellence, teamwork, integrity and mutual respect to advance transformative therapies from discovery to the global marketplace.

About your role:

The Senior Director, Regulatory CMC provides regulatory leadership and oversight in support of multiple early to late phase development programs and commercial products at Seagen. This includes oversight of the development and implementation of global regulatory strategies, ensuring timely preparation, review and submission of documents to regulatory authorities, overseeing conduct of advice meetings with Health Authorities, oversight of the preparation of meeting requests and briefing documents to obtain regulatory advice, collaborating with cross-functional partners and maintaining compliance with applicable regulatory requirements. This person represents the regulatory function on multi-disciplinary teams and ensure integration of company goals into the objectives and activities of the regulatory affairs CMC group. The successful candidate will serve as a resource to team members for the regulatory requirements, processes, and logistics to conduct global drug development activities for compounds from the preclinical stage through the initial marketing application, and ultimately life cycle management.

Responsibilities:

  • Support the creation and implementation of global regulatory CMC strategies by global regulatory CMC leads and regional regulatory leads for clinical and commercial products
  • Provide regulatory guidance and strategy including identifying and assessing regulatory risks
  • Define strategy and review submissions to regulatory authorities including FDA, EMA and other national authorities to support commercial lifecycle management and the conduct of clinical trials and approval of marketing applications (IND, CTA, BLA/NDA, MAA, etc.)
  • Collaborate with global development partners
  • Support technical operations and presentation of development strategies for governance milestones
  • Support Ex-US regulatory expansion initiatives
  • Monitor, analyze, and disseminate intelligence on regulatory matters that may affect ongoing commercial and development programs
  • Oversee the preparation of meeting requests and briefing documents, and the coordination and preparation of teams for health authority meetings
  • Recruit, manage, train and mentor regulatory CMC personnel

Qualifications:

  • PhD in a scientific discipline preferred along with at least 10+ years of experience in Regulatory CMC
  • BS/MS requires at least 15 years of relevant experience in Regulatory CMC
  • Knowledge and understanding of global regulations and guidelines
  • Previous experience in the preparation and submission of regulatory documents
  • Previous experience in attending and leading a team to prepare for major health authority interactions (e.g. FDA pre-NDA/BLA, EOP2, Type C meetings and/or EU oral explanations/scientific advice, etc.)
  • Experience with small molecule and biologic investigational drugs, including late stage development, and marketed products
  • Previous experience with combination products is highly desirable
  • Ability to work in a cross-functional team environment
  • Prior managerial experience, with direct supervision of early- to mid-level regulatory professionals, is highly desirable
  • Strong attention to detail and the ability to handle multiple tasks
  • Excellent organizational, computer and documentation skills and an ability to prioritize effectively
  • Strong interpersonal skills including verbal and written communication

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.



PI138894602