Regulatory Affairs Specialist

Summary:

The Regulatory Affairs Specialist supports a senior regulatory professional by executing against the global regulatory plan for one or more products. The successful candidate will develop an understanding of regulatory guidance and precedent in the oncology setting in order to provide effective regulatory and operational support for routine regulatory submissions.

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

Requirements:

• Bachelor's degree in a life sciences discipline
• General knowledge of the US drug development process and regulatory requirements
• Excellent 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

As the leading employer in our industry in the Pacific Northwest, Seattle Genetics 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 Seattle Genetics, please visit www.seattlegenetics.com.

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.