Associate Director Regulatory Affairs

Company: Seagen
Location: Bothell
Posted on: April 10, 2021

Job Description:

Regulatory Affairs Bothell, Washington Seattle, Washington 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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Keywords: Seagen, Seattle , Associate Director Regulatory Affairs, Executive , Bothell, Washington