Manager Regulatory Affairs

Job content

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 Affairs Manager will report to and support the Regulatory Affairs Associate Director by leading the preparation and submissions of regulatory dossiers to European and Swiss competent authorities, in line with the global regulatory plan for one or more Oncology products.

Principal Responsibilities

• Provide effective operational and regulatory support for assigned regulatory submission and maintenance activities, including preparation and submission of regulatory dossiers, maintenance of regulatory databases and archives.
• Leads the regulatory submissions of clinical trial applications (CTA) and amendments in Europe (EU, UK (post-Brexit) and Switzerland). Support for rest-of-the-world clinical trial applications may be required.
• Contributes to the global regulatory strategy by bringing European insights into discussions.
• Represents EU regulatory in cross-functional teams (Regulatory, Clinical Development, Clinical Operations, Safety, CMC) to ensure optimal execution of the regulatory strategy for development medicinal products
• Manages regulatory affairs consultants/service providers working on the CTA submissions
• Anticipates and brings solutions for potential regulatory risks
• Research relevant regulatory precedents to bring innovative approaches to the cross functional team
• Maintains excellent knowledge of the European regulatory landscape and proactively assesses impact of changes on Seattle Genetics programs
• Communicates and educates cross-functional teams on European regulatory requirements
• Maintains effective archiving and submissions/approvals tracking records
• Participates in process improvement initiatives as required
• Supports the European Regulatory team as required
  

Required Qualifications

• 5+ years in drug development including 3 years managing regulatory submissions, with a primary focus on clinical trial applications and associated tasks
• BSc; MSc or PhD in a life sciences discipline
• Fluent in English (written and spoken)
• Experience in the preparation/submission of regulatory documentation to support clinical trials applications/amendments in the European Union
• Knowledge of the European drug development process and regulatory requirements (knowledge of ex-Europe regulatory environment would be an advantage)
• thorough understanding of local compliance, as well as a sound ethical approach to business
  

Preferred Qualifications

• Excellent oral and written communication skills for effectively interfacing with all levels of management and departments within the company
• Strong technical/analytical skills to identify and solve problems independently
• Proven ability to manage multiple projects, identify and resolve regulatory issues
• Ability to balance regulatory objectives with business objectives
• Willingness to work collaboratively and incorporate diverse perspectives into decision-making
• Self-motivated, assertive, and self-confident with the ability to act with urgency and passion
• Strong organizational skills in order to maintain a high level of productivity, innovation, and priority-setting
• Ability to work under pressure, meeting time sensitive deadlines, while maintaining a high level of quality
• Proactively seeks out and recommends process improvements
• Entrepreneurial, enjoys working in a fast-paced, small-company environment
  

Education

• BSc; MSc or PhD in a life sciences discipline
  

As a leading employer in our industry, 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. To learn more about Seagen, please visitwww.Seagen.com.

Seagen is an equal opportunity employer. All qualified applications will receive consideration for employment.