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Senior Manager Regulatory Affairs

companySeagen
locationBothell, WA, USA
PublishedPublished: 12/8/2023
Full Time

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 Senior Manager, Regulatory Affairs is an individual contributor role that serves as a Global Regulatory Lead for multiple 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.

Principal Responsibilities:

  • Develop integrated regulatory plans that deliver against strategic objectives, maintain compliance, and protect patients
  • Ensure receipt of timely and actionable regulatory authority feedback around key issues and program milestones, by defining the strategy and content to support agency interactions
  • Function as primary liaison with regulatory authorities, including providing complete and timely responses to regulatory authority requests for information
  • Assess regulatory program risks for likelihood and impact; establish mitigation strategies
  • Oversee the planning and preparation of submissions to regulatory authorities, related to initial IND/CTA submission and maintenance
  • Advise on regulatory requirements, expected outcomes, and changes to landscape
  • May provide guidance or coaching to other professionals
  • Other duties as assigned

Qualifications:

  • Demonstrates proficiency (teaches others, makes improvements) in key areas of responsibility, which is typically associated with Bachelor’s degree in a life sciences discipline and 6+ years of regulatory experience with drug or therapeutic biologic products in oncology.
  • Proficient in:
  • Code of Federal Regulations Title 21 and FDA Guidance
  • Regional Health Authority Regulations and Guidance
  • Global Regulatory Expectations
  • Drug Development Process
  • Demonstrated ability to:
  • Develop and deliver multi-mode communications (e.g., written, verbal, presentations) that convey a clear understanding of the unique needs of different audiences
  • Build partnerships and work collaboratively with others to meet shared objectives.
  • Gain the confidence and trust of others through honesty, integrity, and authenticity
  • Actively learn through experimentation when tackling new problems, using both successes and failures as learning fodder
  • Secure and deploy resources effectively and efficiently
  • Operate effectively, even when things are not certain, or the way forward is not clear
  • Make good and timely decisions that keep the organization moving forward
  • See ahead to future possibilities and translate them into breakthrough strategies
  • Operate effectively, even when things are not certain, or the way forward is not clear
  • Make good and timely decisions that keep the organization moving forward
  • See ahead to future possibilities and translate them into breakthrough strategies


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.  

The hiring pay range for this position is $136,000 to $176,000 per year based on skills, education and experience relevant to the role. Other components of total compensation include a competitive equity grant at the time of hire and an annual bonus. 

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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