SeattleRecruiter Since 2001
the smart solution for Seattle jobs

Senior Regulatory Affairs Specialist

Company: Seagen
Location: Bothell
Posted on: November 22, 2021

Job Description:

Description

Position at Seagen

Summary:

The Senior Regulatory Affairs Specialist supports a senior regulatory professional by executing against the global regulatory plan for one or more products. The successful candidate will provide effective regulatory and operational support for both routine submissions and responses to FDA requests.

Responsibilities:

  • Provide regulatory representation and support at cross-functional team study meetings
  • Provide support for the preparation of regulatory submissions including Clinical Trial Applications (CTAs), routine IND submissions, supplemental marketing applications, and routine reports
  • Perform regulatory assessments to inform global regulatory plans
  • Responsible for regulatory maintenance activities
  • Prepare responses to health authority requests and assist with preparations for health authority interactions
  • Review individual submission components for quality and completeness
    Qualifications:
    • Bachelor's degree in a life sciences discipline; advanced degree desirable
    • 2+ years of relevant experience in regulatory affairs with drug or therapeutic biologic products or equivalent
    • 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 in Bothell, WA, Seattle, WA, or West Coast locations

      As the leading employer in our industry in the Pacific Northwest, Seagen 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 Seagen, please visit .

      Seagen 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 prevent the spread of COVID-19, and as an integral part of its public health and safety measures, Seagen requires that all newly-hired employees be fully vaccinated against COVID-19 before commencing employment, subject to reasonable accommodation and other requirements of applicable federal, state, and local law.

      #LI-TC2

Keywords: Seagen, Seattle , Senior Regulatory Affairs Specialist, Other , Bothell, Washington

Click here to apply!

Didn't find what you're looking for? Search again!

I'm looking for
in category
within


Log In or Create An Account

Get the latest Washington jobs by following @recnetWA on Twitter!

Seattle RSS job feeds