The Seattle Genetics Regulatory Affairs Fellowship is a one-year, experiential program at Seattle Genetics based in Bothell, WA. The purpose of this program is to prepare PharmD fellows for career opportunities in pharmaceutical Regulatory Affairs by providing in-depth biopharmaceutical industry experiences and enhancing regulatory knowledge and application.
The Seattle Genetics Regulatory Affairs Fellowship provides a unique opportunity for a PharmD graduate to gain training and hands-on experience in a specialized area of Regulatory Affairs. The fellow will work closely with Regulatory Science, Regulatory Intelligence and Regulatory Labeling leads on marketed and development-stage products. The fellow will also have the opportunity to interact cross-functionally with a broad group of team members and key stakeholders, including: Clinical Development, Drug Safety, Clinical Pharmacology, Biostatistics, Commercial, and Medical Affairs.
The fellow will have the opportunity to support Seattle Genetics’ marketed products, including ADCETRIS® (brentuximab vedotin), PADCEV® (enfortumab vedotin), and TUKYSA® (tucatinib), as well as pipeline products, including investigational agents in both early and late stages of clinical development.
Participating in the authoring and/or cross-functional review of marketing applications and clinical trial applications
Supporting preparation for Health Authority interactions and label negotiations
Analyzing the evolving regulatory landscape for impact on our products and processes in support of regulatory decision making
Researching and presenting on competitor labels and labeling precedents
Supporting the development and maintenance of Target Product Labels, Company Core Data Sheets, USPIs and Product Monographs for initial and supplemental marketing applications
Working collaboratively with internal partners and stakeholders to inform and achieve desired regulatory outcomes
Opportunity to help shape the fellowship for future applicants
A Doctor of Pharmacy (PharmD) degree from an ACPE accredited institution
Analytical, planning, and organizational skills
Excellent communication skills, including oral, written and presentation
Self-motivated, energetic, able to work and learn independently
Ability to thrive in a fast-paced, dynamic environment
Good scientific judgement, attention to detail, and excellent interpersonal skills, including ability to work effectively cross culturally and cross functionally
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.
Application deadline is Wednesday, November 25th. Please include include the following with your application:
Letter of intent
3 Professional References (phone number and email) upon formal request
Employer will assist with relocation costs.
Internal Number: 2020-763
Seagen is a global biotechnology company that develops and commercializes transformative cancer therapies. We’re driven by a singular mission—to make a difference for people impacted by cancer.
As an industry leader in antibody–drug conjugate (ADC) technology, we pioneered the science of harnessing antibodies to deliver cell-killing agents directly to cancer cells. This technology is the foundation of two of our approved medicines—ADCETRIS® (brentuximab vedotin) and PADCEV® (enfortumab vedotin-ejfv).
Today, our research efforts are focused on advancing a pipeline of novel targeted therapies, including TUKYSA® (tucatinib), recently approved for certain metastatic HER2+ breast cancers. We’re also leveraging our expertise in empowered antibodies to build a portfolio of proprietary immuno-oncology agents.