Associate Director, Regulatory Affairs Labeling

Regulatory Affairs Bothell, Washington South San Francisco, California


Description

Summary: 

The Associate Director in Regulatory Labeling provides strategic regulatory leadership and drives cross-functional development and execution of global labeling strategy for late stage and marketed products. This role offers high visibility and the opportunity to work directly with senior leaders across the Development and Commercial organizations on new marketing authorization applications, label expansions, and product launches. This is an opportunity to join a rapidly growing Regulatory organization and provide a direct impact on new label development and process initiatives at Seattle Genetics.

 

Responsibilities:

  • Develops global labeling strategy for registrational filings
  • Manages the development, maintenance, and implementation of high quality labeling including Company Core Data Sheets (CCDS), Target Product Labels (TPL), and regional labels (e.g USPIs, PPI/Med Guides, and Product Monographs)
  • Leads cross-functional Label Working Group meetings and supports presentation to Label Committee
  • Manages label negotiations with Health Authorities
  • Contributes to and reviews regulatory documents to support regional label updates
  • Collaborates with cross-functional team members to develop labeling strategy, scenario planning, key claims, and message maps
  • Provides expertise on regional labeling regulations, industry best practices, and competitor label assessments
  • Represents Regulatory Affairs Labeling on Global Regulatory Teams and Core Submission Teams
  • Leads process improvement initiatives and contributes to defining cross-functional business processes
  • Trains and mentors labeling associates and managers

 Qualifications: 

  • Bachelor’s degree in a life sciences discipline
  • Minimum of 7 years of relevant experience in Regulatory Affairs with at least 3 years of direct experience in prescription drug/biologic labeling
  • Experience leading cross-functional meetings and facilitating strategic discussions
  • Experience negotiating with internal stakeholders and health authorities on complex labeling issues
  • Excellent verbal and written communication skills
  • Detail oriented, highly organized, with the ability to deliver against tight timelines

 

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.