Sr. Director, Regulatory Affairs

Location
Bothell, WA, United States
Posted
Aug 28, 2018
Ref
o4Qc8fwY
Hotbed
BioForest
Required Education
Doctorate/PHD/MD
Position Type
Full time
Summary:

The Sr. Director, Regulatory Affairs provides strategic regulatory leadership and oversight in support of multiple early and late phase development programs at Seattle Genetics. This includes oversight of the development and implementation of global regulatory strategies, ensuring timely preparation, review and submission of documents to regulatory authorities, oversight of the preparation of meeting requests and briefing documents to obtain regulatory advice, collaborating with development partners, and maintaining compliance with applicable regulatory requirements. 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 development and implementation of regulatory strategies by global regulatory leads and regional regulatory leads
  • 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 the conduct of clinical trials and approval of marketing applications (IND, CTA, BLA/NDA, MAA, etc)
  • Collaborate with global development partners
  • Support development 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 development programs
  • Oversee the preparation of meeting requests and briefing documents, and the coordination and preparation of teams for health authority meetings
  • Manage, train and mentor regulatory affairs personnel


Qualifications:
  • MD, PhD or PharmD in a scientific discipline preferred along with 10+ years of experience in Regulatory Affairs
  • BS/MS requires at least 15 years of relevant experience in Regulatory Affairs
  • Oncology experience required
  • 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 meetings, advisory committee meetings and/or EU oral explanations/scientific advice, etc.)
  • Experience with investigational drugs, including late stage development, and marketed products
  • Ability to work in a cross-functional team environment
  • Prior managerial experience, with direct supervision of mid- to senior-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.