Associate Director Regulatory Affairs

Regulatory Affairs Bothell, Washington South San Francisco, California


Description

Summary: 

The Associate Director of Regulatory Affairs will provide regulatory leadership for the development of global regulatory strategies and execution of submissions to support early stage programs in line with the Global Product Team goals and objectives. The successful candidate will serve as a leader and resource to team members for strategic input, regulatory requirements, processes, and logistics to conduct global drug development activities for assigned programs. 

 Responsibilities: 

  • Serve as Global Regulatory Lead, sole regulatory representative on the Global Product Team (GPT), for assigned programs 
  • 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 
  • Oversee the planning and preparation of submissions to health authorities, related to IND/CTA maintenance 
  • Advise GPT and management on regulatory requirements, expected outcomes, and changes to landscape 
  • Monitor regulatory intelligence, to bring innovative approaches to cross‑functional teams and maintain knowledge of the regulatory landscape to pro-actively assess impact of changes on development plans 

Qualifications: 

  • PhD, PharmD, Master’s or Bachelor’s degree in a life sciences discipline 
  • Minimum of 7 years regulatory experience, with at least 5 years in a similar strategic role with drug or therapeutic biologic products 
  • Oncology experience strongly preferred 
  • In depth knowledge of global regulatory requirements and expedited development programs in oncology 
  • Experience in the preparation and submission of regulatory documentation to support development activities 
  • Experience leading a team to prepare and execute health authority interactions 
  • Excellent oral and written communication skills for effectively interfacing with all levels of management and departments within the company 
  • Effective technical/analytical skills to identify and solve problems independently 
  • Proven ability to manage multiple projects, identify and resolve regulatory issues 
  • Highly adept at managing conflicting priorities and adhering to tight timelines 
  • Proficient at thinking outside the box and driving teams to decisions, considering and accounting for multiple options and opinions 
  • Self-motivated, assertive, and self-confident with the ability to act with urgency and passion 
  • Entrepreneurial, enjoys working in a fast-paced environment 
  • Able to travel for meetings with corporate partners and health authorities 

 

 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.  

#LI-TC2