Associate Manager Regulatory Affairs CMC

Development Bothell, United States


Description

Position at Seagen

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 Associate Manager, Regulatory CMC supports a senior regulatory professional by executing against the global regulatory plan for one or more products. This position provides regulatory and operational support for both routine regulatory submissions and responses to regulatory authority information requests. 
 
Principal Responsibilities 

  • Provide regulatory representation and support at cross-functional team study meetings  
  • Perform regulatory assessments to inform global regulatory plans 
  • Responsible for regulatory maintenance activities  
  • Prepare responses to regulatory authority requests and assist with preparations for regulatory authority interactions 
  • Review individual submission components for quality and completeness 

Qualifications 

  • Bachelor's degree in scientific discipline and a minimum of 2 years regulatory experience 
  • Biologic product experience preferred but not required 
  • General knowledge of the drug development process and regional regulatory requirements 
  • Strong written and verbal communication skills 
  • Able to manage conflicting priorities and adhere to tight timelines 
  • Proven ability to work with a high level of integrity, accuracy, and attention to detail 
  • Strong organizational skills to maintain a high level of productivity, innovation, and priority-setting 

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. 

#LI-MD1