Seattle Genetics
Associate Director, Regulatory Affairs
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:
Reporting to the Senior Director or Executive Director, Regulatory Affairs, the Associate Director will contribute to the development and execution of an effective registrational strategy for investigational products and/or additional indications for marketed products. The successful candidate will serve as a regulatory contact within an internal matrixed team environment, as well as with health authorities and corporate partners.
Responsibilities:
- Develop integrated regulatory plans that deliver against strategic objectives, maintain compliance, and protect patients.
- Ensure receipt of timely and actionable health authority feedback around key issues and program milestones, by defining the strategy and content to support agency interactions.
- Function as primary liaison with health authorities, including providing complete and timely responses to health authority requests for information.
- Assess regulatory program risks for likelihood and impact; establish mitigation strategies.
- Support product labeling efforts from inception to final negotiation.
- Oversee the planning and preparation of submissions to regulatory authorities, both related to IND maintenance and marketing authorization.
- Advise on regulatory requirements, expected outcomes, and changes to landscape.
Qualifications:
- Bachelor’s degree in a life sciences discipline and a minimum of 7 years regulatory experience.
- Oncology experience required.
- Knowledge of US regulatory requirements and opportunities for expediting development programs for serious conditions.
- Familiarity with labeling and CMC concepts is desirable.
- Experience interacting with health authorities.
- Able to manage conflicting priorities and adhere to tight timelines.
- Able to consider and account for multiple options and opinions.
- Able to travel for meetings with corporate partners and regulatory authorities.
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.seattlegentics.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: 04/13/2018
|
