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 Regulatory CMC Manager supports a senior regulatory CMC professional by executing against the global regulatory CMC plan for one or more products. This position represents Regulatory on cross-functional teams and manages the development and preparation of regulatory documentation to regulatory authorities. The successful candidate will plan, prepare, and gain appropriate internal review and approval of CMC-related regulatory documentation to ensure its suitability for submission to health authorities. They will provide regulatory guidance to biologics, antibody-drug conjugate, and novel modality project teams to ensure compliance with relevant regulations, guidelines, and industry standards and also support Regulatory systems, such as change control and knowledge management. 

Our ideal new colleague is a good team player, dynamic, optimistic, accurate, result-oriented, hard-working and creative. They are skilled at developing interpersonal relationships and demonstrate open, clear, persuasive communication with internal and partner teams. They strive for the best performance and are curious with a willingness to learn. 

 
Principal Responsibilities: 

  • Prepare, maintain and/or coordinate global regulatory submissions (INDs, CTAs, marketing applications, amendments) in accordance with applicable regulations 
  • Communicate regulatory requirements to product development teams and provide clarity on regulatory expectations and timelines 
  • Provide regulatory representation at cross-functional team meetings, including tactical support and timelines  
  • Prepare responses to regulatory authority requests and assist with preparations for regulatory authority interactions  
  • Review individual submission components for quality and completeness 
  • Work with contract manufacturing organizations (CMO) and contract research organizations (CRO) for ex-US regulatory submissions 

Qualifications: 

  • Bachelor's degree in scientific discipline and a minimum of 4 years regulatory experience; advanced degree desirable  
  • Biotechnology experience preferred 
  • Solid knowledge and understanding of the drug development process and regional regulatory requirements 
  • Experience in the preparation/submission of regulatory documentation to support regulatory submissions 
  • Excellent oral and written communication skills  
  • Strong technical/analytical skills to identify and solve problems independently 
  • Proven ability to manage multiple projects, identify and resolve regulatory issues 
  • Willingness to work collaboratively 
  • Self-motivated, assertive, and self-confident 
  • Strong organizational skills to maintain a high level of productivity, prioritize work and coordinate work done by matrixed teams 
  • Ability to work under pressure, meeting time sensitive deadlines, while maintaining a high level of quality 
  • Proactively seeks out innovations for regulatory submissions and recommends process improvements 
  • Enjoys working in a fast-paced, environment 
     

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. 

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