What are the responsibilities and job description for the Manager, Regulatory Affairs position at Seagen?
Seagen is a global, multi-product biotechnology company dedicated to developing and commercializing transformative cancer medicines. As the industry leader in antibody-drug conjugate (ADC) technology, we pioneered a new generation in the science of harnessing antibodies to deliver cell-killing agents directly to cancer cells. Seagen’s dedication to improving the lives of cancer patients goes beyond science, and we believe that every employee has a role in contributing to this mission. By working together with a shared dedication and diverse perspectives, we are able to reach our full potential and make a real difference in the world. Seagen is a fast-growing company and has an abundance of opportunities available for you to grow your career. Put your passion to work at Seagen and join us!
Summary:
The Manager, Regulatory Affairs supports a senior regulatory professional by executing against the global regulatory plan for one or more products. This position represents Regulatory on cross-functional teams and manages the development and preparation of regulatory documentation to regulatory authorities.
Responsibilities:
- Provide regulatory representation at cross-functional team meetings, including tactical support and clarity on regulatory expectations and timelines
- Prepare, maintain, and/or coordinate regulatory submissions in accordance with applicable regulations
- May function as primary liaison with regulatory authorities for routine communications in support of submissions
- Assist in preparation for regulatory authority interactions
- Provide tactical and strategic regulatory representation on development teams
- Develop, prepare and review regulatory submissions for assigned projects
- Communicate regulatory policy to development teams and provide clarity on regulatory expectations and timelines
- Prepare, maintain and/or coordinate global regulatory submissions (INDs, CTAs, marketing applications) in accordance with applicable regulations
- Serve as primary contact to FDA (or other relevant regulatory authorities) for routine communications in support of submissions
- Assist in preparation for and participate in regulatory authority meetings
- Work with contract research organizations for ex-US regulatory submissions
Qualifications:
- Bachelor's degree in a life sciences discipline and a minimum of 4 years regulatory experience; advanced degree desirable
- Oncology experience preferred
- Solid knowledge and understanding of the drug development process and regional regulatory requirements
- Experience in the preparation/submission of regulatory documentation to support regulatory submissions
- Excellent oral and written communication skills
- Strong technical/analytical skills to identify and solve problems independently
- Proven ability to manage multiple projects, identify and resolve regulatory issues
- Willingness to work collaboratively
- Self-motivated, assertive, and self-confident
- Strong organizational skills in order to maintain a high level of productivity, innovation, and priority-setting
- Ability to work under pressure, meeting time sensitive deadlines, while maintaining a high level of quality
- Proactively seeks out and recommends process improvements
- Enjoys working in a fast-paced, environment
- Ability to work in Bothell, WA, Seattle, WA or San Francisco, CA locations
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.
To prevent the spread of COVID-19, and as an integral part of its public health and safety measures, Seagen requires that all newly-hired employees be fully vaccinated against COVID-19 before commencing employment, subject to reasonable accommodation and other requirements of applicable federal, state, and local law.
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