Manager, Regulatory Affairs

Location
Bothell, WA, United States
Posted
Oct 04, 2019
Ref
oScfbfwe
Required Education
Bachelors Degree
Position Type
Full time
Summary:

Seattle Genetics is hiring a Manager, Regulatory Affairs to be a part of our exciting growth as we expand our Regulatory team. The successful candidate will represent Regulatory Affairs on cross-functional teams, working in a collaborative scientifically driven environment to successfully deliver a robust pipeline of oncology products to patients. As a 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 global clinical trials, including preparation of regulatory documentation to health authorities, for a late stage oncology product.

Responsibilities:
  • Represent Regulatory Affairs at cross-functional team meetings providing both tactical support and clarity on regulatory expectations and timelines
  • Provide support for large, global registration trials
  • Prepare, maintain, and/or coordinate complex regulatory submissions in accordance with applicable regulations, including responses to health authority questions
  • Serve as US region lead for an early stage product; responsible for coordinating submission and maintenance of an IND

Requirements:
  • Bachelor's Degree in scientific discipline or equivalent; advanced degree desirable
  • Oncology experience is desirable
  • 3+ years of relevant experience in regulatory affairs with drug or therapeutic biologic products or equivalent; prior experience coordinating responses to regulatory authority questions 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.