Director Regulatory Affairs
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!
The Director of Regulatory Affairs provides regulatory leadership in support of early-stage development programs. This includes the development and implementation of regulatory strategy, ensuring timely preparation, review, and submission of documents to regulatory authorities, and maintaining compliance with applicable regulatory requirements. This position represents the regulatory function on multidisciplinary teams and serves as a resource to team members for the regulatory requirements, processes, and logistics to conduct global drug development activities.
- Develop and implement regulatory strategy to support global clinical trials including regulatory authority meetings, IND submissions, and Clinical Trial Application (CTAs) submissions
- Serve as Global Regulatory Lead (GRL) representing the regulatory function on cross-functional development teams
- Provide regulatory guidance and strategy including identifying and assessing regulatory risks
- Plan, prepare, and review submissions to regulatory authorities including FDA, EMA, and other national authorities to support the conduct of clinical trials
- Lead regulatory activities for assigned projects in line with US, European, ICH, and other applicable requirements to ensure compliance
- Manage the regulatory aspects of products and projects including achievement of timelines and deliverables
- Ensure that regulatory documents are accurate, complete, and verifiable, and confirm compliance with regulatory requirements
- Monitor, analyze, and disseminate intelligence on regulatory matters that may affect ongoing development programs
- Prepare meeting requests, briefing documents, coordinate and prepare teams for meetings, and interface with regulatory authorities; be primary liaison with regulatory authorities for day-to-day interactions
- Coordinate and prepare responses to requests for information from regulatory authorities
- Manage, train and mentor regulatory affairs personnel
- PhD, PharmD, Master’s or Bachelor’s degree in a life sciences discipline
- Minimum of 10 years of regulatory experience, with at least 5 years in a similar strategic role with drug or therapeutic biologic products
- Oncology experience required
- In-depth knowledge of global regulations, guidelines, and expedited development programs
- Experience in the preparation and submission of regulatory documentation to support development activities, marketing applications, and marketed products
- Experience in attending and leading a team to prepare for major regulatory authority interactions
- Prior managerial experience, with direct supervision of mid- to senior-level regulatory professionals, is highly desirable
- Excellent oral and written communication skills for effectively interfacing with all levels of management and cross-functional departments within the company
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.