Seagen

Associate Director Regulatory CMC

Development - Bothell, United States

Description

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 Director, Regulatory CMC provides regulatory leadership in support of one or more development or commercial 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. This position represents the regulatory function on multi-disciplinary teams and serves as a resource to team members for the regulatory requirements, processes, and logistics to conduct global drug development activities for compounds from the preclinical stage through the initial marketing application, and for post-approval life cycle management.

Principal Responsibilities:

• Provide effective strategic and tactical leadership to support global regulatory plans including:
• Develop and implement regulatory strategy and submission plans to support pivotal global clinical trials including regulatory authority meetings, INDs, CTAs, and marketing applications
• Develop and implement regulatory strategy and submission plans to support life cycle management of global markets
• Represent the 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
• Serve as point of contact with regulatory authorities, as applicable
• 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

Qualifications:

• Bachelor's degree in a life sciences discipline and a minimum of 8 years regulatory experience; advanced degree desirable
• Biologic product experience highly desirable
• Knowledge and understanding of global regulations and guidelines
• Experience in the preparation and submission of regulatory documentation to support all regulatory programs throughout product lifecycle
• Experience leading a team to prepare and execute major regulatory authority interactions
• 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 interpret and understand regulations in the context of the scientific and commercial environment and 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 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
• Entrepreneurial, enjoys working in a fast-paced, environment
• Prior managerial experience is highly desirable

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.

Apply:

Seagen

Seagen is an Equal Opportunity Employer

Submitted: 08/12/2022