Seagen

Senior Specialist Regulatory Affairs Labeling

Description

Summary:

The Senior Specialist supports the Regulatory Labeling Lead in the development, preparation, and maintenance of regulatory labeling documents. Working collaboratively and cross-functionally, this This role offers high visibility and the opportunity to work directly with senior leaders across the Development and Commercial organizations on new marketing authorization applications, label expansions, and product launches. This is an opportunity to join a rapidly growing Regulatory organization and provide a direct impact on new label development and process initiatives at Seattle Genetics. The successful candidate should possess an eagerness to learn, an aptitude for strategic thinking, and a focus on delivering for patients.

Principal Responsibilities:

• Support drafting, review, and document adjudication of CCDS, USPI, and TPLs
• Support health authority label negotiations and response to questions
• Participate in reviews of regional labels
• Support Label Committee and Label Working Group meetings, including preparation of meeting pre-reads and documentation of meeting minutes
• Provide research on label precedent and competitor label intelligence
• Attend Global Regulatory Team and Submission Working Group meetings
• Contribute to department process improvement initiatives

Qualifications:

• 2 years of pharmaceutical industry experience
• Strong verbal and written communication skills
• Detail oriented, highly organized, with the ability to deliver against tight timelines
• General knowledge of the drug development process and regulatory requirements
• Strong technical systems skills (e.g. word processing, excel spreadsheets, databases, literature searches)

Education

• Bachelor’s degree (BA or BS) in a scientific discipline

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: 04/02/2021