Sr. Manager, Regulatory Affairs
This position supports a senior regulatory professional by executing against the global regulatory plan for one or more products. The successful candidate will represent Regulatory Affairs on cross-functional teams and be responsible for the development and preparation of regulatory documentation to health authorities.
- Represent Regulatory Affairs at cross-functional team meetings providing both tactical support and clarity on regulatory expectations and timelines
- Support initiation of large, global registration trials
- Prepare, maintain, and/or coordinate complex regulatory submissions in accordance with applicable regulations, including responses to health authority questions and meeting briefing packages
- Serve as US region lead for an early stage product; responsible for coordinating submission and maintenance of an IND
- Serve as a resource for more junior members of the team
- Bachelor’s Degree in scientific discipline or equivalent; advanced degree desirable
- Oncology experience is desirable
- 4+ years of relevant experience in regulatory affairs with drug or therapeutic biologic products or equivalent; prior experience coordinating responses to regulatory authority questions strongly desired
- Excellent written and verbal communication skills
- Able to manage conflicting priorities and adhere to tight timelines
- 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
- Ability to work with minimal oversight
- International clinical trial experience preferred
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.