Seattle Genetics
Senior Regulatory Affairs Specialist
Regulatory Affairs - Bothell, Washington
Description
Seattle Genetics is an emerging global multi-product biotechnology company that develops and commercializes innovative antibody-based therapies for the treatment of cancer. The company’s industry-leading antibody-drug conjugate (ADC) technology harnesses the targeting ability of antibodies to deliver cell-killing agents directly to cancer cells. In addition to one marketed product, we are advancing a strong product pipeline of novel therapies for solid tumors and blood-related cancers designed to address significant unmet medical needs and improve treatment outcomes for patients.
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.
- 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.
- Two 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.
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, color, religion, sex, national origin, protected veteran status, or disability status.
Apply:
Seattle Genetics
Seattle Genetics is an Equal Opportunity Employer
Submitted: 02/01/2019
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