The Regulatory Affairs - Companion Diagnostics Lead is accountable for developing and overseeing the execution of companion diagnostic (CDx) regulatory strategy across multiple oncology programs. The successful candidate will operate as a subject matter expert, aligning the CDx strategy with the broader strategic program objectives and interfacing with CDx partners and health authorities.
Providing strategic CDx regulatory guidance to support program objectives
Integrating CDx and therapeutic regulatory strategy to support product registration
Providing regulatory leadership to internal regulatory, development, and translational sciences teams
Guiding regulatory interactions with diagnostic partners to ensure alignment with respect to strategy and execution
Preparing internal teams for meetings with health authorities where CDx strategy will be discussed
Evaluating regulatory submissions to CDRH prepared by diagnostic partners
Bachelor's degree in a life sciences discipline and a minimum of 8+ years regulatory experience, including 3 years focused on the development of CDx strategies
Oncology experience preferred
Knowledge of global CDx regulations and guidelines
Familiarity with the development of product labeling and opportunities for expediting development programs for serious conditions is desirable
Experience interacting with health authorities
Able to consider and account for multiple options and opinions
Able to travel for meetings with corporate partners and regulatory authorities
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.