Regulatory Affairs Specialist, Regulatory Affairs
The Regulatory Affairs Specialist supports a senior regulatory professional by executing against the global regulatory plan for one or more products. The successful candidate will develop an understanding of regulatory guidance and precedent in the oncology setting.
- Prepare routine regulatory submissions for investigational and marketed products
- Assist in preparing responses to health authority requests for general information
- Assist with preparations for health authority interactions
- Review individual submission components for quality and completeness
- Interface with Regulatory Operations to define and track submission content
- Bachelor's degree in a life sciences discipline
- General knowledge of the drug development process in the U.S.
- Strong written and verbal communication skills
- Strong organizational skills; able to manage conflicting priorities and adhere to tight timelines
- High attention to detail
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.