Seagen

Regulatory Affairs Specialist

Development - Bothell, United States

Description

Seagen is a global, multi-product biotechnology company dedicated to developing and commercializing transformative cancer medicines. As the industry leader in antibody-drug conjugate (ADC) technology, we pioneered a new generation in the science of harnessing antibodies to deliver cell-killing agents directly to cancer cells. Seagen’s dedication to improving the lives of cancer patients goes beyond science, and we believe that every employee has a role in contributing to this mission. By working together with a shared dedication and diverse perspectives, we are able to reach our full potential and make a real difference in the world. Seagen is a fast-growing company and has an abundance of opportunities available for you to grow your career. Put your passion to work at Seagen and join us!

Summary

The Regulatory Affairs Specialist supports a Global Regulatory Lead (GRL) by executing against the global regulatory plan for one or more early-stage programs. This position provides regulatory support for routine regulatory submissions. The successful candidate will develop an understanding of regulatory guidance and precedent in the oncology setting. Under general supervision, the Regulatory Affairs Specialist will provide sound regulatory input and advice across projects as applicable.

Principal Responsibilities:

• Responsible for preparing and managing routine regulatory submissions for investigational oncology products
• May serve as regulatory representative on cross-functional study team meetings
• May perform regulatory research and assessments to inform global regulatory plans
• May support preparation of responses to health authority requests and health authority interactions
• May participate in other projects and perform other duties as directed

Qualifications:

• Bachelor’s degree in a life sciences discipline
• 1+ year of relevant regulatory experience and/or regulatory affairs degree is preferred
• General knowledge of the drug development process and regional regulatory requirements
• Strong written and verbal communication skills
• Strong organizational 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 information seeking skills and ability to work under moderate supervision
• Ability to work in Bothell, Washington is preferred but not required

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, visit www.seagen.com.

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.

Apply:

Seagen

Seagen is an Equal Opportunity Employer

Submitted: 05/13/2022