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.
Regulatory Affairs . Bothell, Washington
Seattle Genetics is hiring a Sr Manager Regulatory Affairs, come be a part of our exciting growth as we expand our Regulatory team. This position will report to a Director of Regulatory Affairs and have the opportunity to collaborate cross functionally in a scientifically-driven environment and be a part of a team that is successfully delivering a robust pipeline of oncology product to patients. As US regional lead, this position will be responsible for guiding US regulatory strategy for a new product starting with an IND filing onward through registration. In addition, this role will support evaluation of new indications in a later stage marketed product by helping to respond to health authority questions, assisting in creation of meeting materials in support of regulatory interactions, and supporting global clinical trials. The successful candidate will represent Regulatory Affairs on cross-functional teams and mentor a junior regulatory affairs position.
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.