Senior Manager Regulatory Affairs LATAM

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 Senior Manager, Regulatory Affairs LATAM will serve as the Regional Regulatory Lead for one or more early, late stage, and marketed assets. The successful candidate will have primary responsibility for developing regional regulatory strategies and implementing regulatory activities and submissions in line with program goals and objectives. This position represents the LATAM regulatory function on cross-functional teams and serves as a resource to team members for the regulatory requirements, processes, and logistics to conduct regional clinical trial and marketing registration activities. The successful candidate will provide regulatory support to Director, Regulatory Affairs LATAM and work closely with Partner and Internal counter parts, CMC, Quality, Commercial and Medical Colleagues.  

Responsibilities:  

  • Develop and implement regulatory strategy and submission plans to support clinical trials and marketing applications including regulatory authority meetings and response to agency questions for LATAM region 
  • Supports Regulatory Director by preparing supportive documentation for regulatory deliverables, including for example regulatory landscapes or research for the regulatory strategy and/or target product label 
  • Conduct regulatory review of documents for health authority submissions 
  • Represent the LATAM 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 
  • 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 for the region 
  • Proposing/looking for improvements to our current systems and process, sharing best practices and ensuring LATAM specifics are consolidated within the global organization 
  • Collaborate with external partners  

Requirements:  

  • BS/BA with 5+ years of relevant experience in Regulatory Affairs or MS/PhD/PharmD in a scientific discipline with 3+ years of experience in Regulatory Affairs 
  • Oncology experience highly desirable 
  • Knowledge and understanding of Emerging Markets especially LATAM regulations and guidelines 
  • Previous experience in the preparation and submission of regulatory documents 
  • 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.   

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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