Manager, Regulatory Intelligence

Location
Bothell, WA, United States
Posted
Dec 04, 2018
Ref
omYY8fwa
Hotbed
BioForest
Required Education
Bachelors Degree
Position Type
Full time
Summary:

The Manager, Regulatory Intelligence is responsible for monitoring the regulatory landscape to identify and understand emerging changes that may impact the Company's global drug development programs and regulatory strategies. The role will be primarily focused on US regulatory intelligence, with expansion to global policy as a secondary component. The Manager, Regulatory Intelligence is responsible for developing and maintaining an internal system to identify, evaluate, track, and internally communicate regulatory trends and issues.

Responsibilities:

  • Develop and maintain effective processes and systems for monitoring, evaluating, and reporting regulatory intelligence
  • Communicate new and emerging regulatory requirements and key insights and intelligence to regulatory leadership and cross-functional colleagues
  • Identify and align on potential implications of emerging regulatory requirements and deliver organizational comments on proposed FDA guidance documents and/or other external requests for industry input by regulatory bodies
  • Identify strategic opportunities and ensure organizational contribution to and participation on pertinent committees, advisory panels, and other regulatory forums
  • Maintain current knowledge base on existing and emerging regulations, standards, and guidance documents


Qualifications:

  • Bachelor's degree in a life sciences discipline; advanced degree preferred
  • 4 years of relevant experience in regulatory affairs with drugs or biologics
  • Solid understanding of US regulatory requirements governing drugs and biologics in all phases of development
  • Ability to understand and communicate new or evolving changes in US regulatory requirements and partner effectively with cross-functional team members
  • Excellent written and oral communication skills
  • Proven ability to work with a high level of integrity, accuracy, and attention to detail
  • Strong organizational skills in order to maintain a high level of productivity, innovation, and priority-setting


Location:

  • Seattle/Bothell


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.