PharmD Fellow: Oncology Regulatory Affairs

Regulatory Affairs Bothell, Washington


Description

Summary:

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.

Responsibilities:

  • 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

Qualifications:

  • 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.

To learn more about the Seattle Genetics Fellowship program, please visit: https://bit.ly/3k8yaiW

Application deadline is Wednesday, November 25th. Please include include the following with your application:

  • Curriculum vitae
  • Letter of intent
  • 3 Professional References (phone number and email) upon formal request

Additional questions? Please email fellowship@seagen.com.