Seagen
Associate Director Regulatory Affairs
Regulatory Affairs - Bothell, Washington - Seattle, Washington
Description
Summary
The Associate Director, Regulatory Affairs will serve as the Global Regulatory Lead (GRL) for one or more development programs. The successful candidate will have primary responsibility for developing global regulatory strategies and implementing regulatory activities and submissions in line with program goals and objectives. This position represents the regulatory function on cross-functional teams and serves as a resource to team members for the regulatory requirements, processes, and logistics to conduct global drug development activities.
Responsibilities:
- Provide effective strategic and tactical leadership to support global regulatory plans including:
- Developing and implementing regulatory strategy and submission plans to support global pivotal clinical trials including regulatory authority meetings, INDs, CTAs, and marketing applications
- Conduct regulatory review of documents for health authority submissions
- Represent the regulatory function on cross-functional teams and communicate regulatory requirements to ensure optimal execution of the regulatory strategy
- Provide regulatory guidance and strategy including identifying and assessing regulatory risks
- Serve as point of contact with regulatory authorities, as applicable
- Monitor and research regulatory intelligence, to bring innovative approaches to the cross‑functional team and maintain knowledge of the regulatory landscape to pro-actively assess impact of changes on development plans
- Collaborate with global development partners
Requirements:
- BS/BA with 8+ years of relevant experience in Regulatory Affairs or MS/PhD/PharmD in a scientific discipline with 5+ years of experience in Regulatory Affairs
- Oncology experience highly desirable
- Knowledge and understanding of global regulations and guidelines
- Previous experience in the preparation and submission of regulatory documents
- Previous experience leading a team to prepare for and carry out major health authority interactions
- Experience with investigational drugs, including those in late-stage development
- Ability to work in a cross-functional team environment
- Strong attention to detail and the ability to handle multiple tasks
- Excellent organizational, computer and documentation skills and an ability to prioritize effectively
- Strong interpersonal skills including verbal and written communication
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: 01/08/2021
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