Seagen

Regulatory Affairs Specialist

Description

Summary

The Regulatory Affairs Specialist supports a Global Regulatory Lead (GRL) by executing against the global regulatory plan for one or more products. This position provides regulatory and operational 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 assist in preparation of responses to health authority requests and preparations for health authority interactions
• May participate in other projects and perform other duties as directed by senior regulatory personnel

Qualifications:

• Bachelor’s degree in a life sciences discipline
• 1+ year of relevant regulatory experience 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.

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 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.

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Seagen

Seagen is an Equal Opportunity Employer

Submitted: 01/29/2021