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!
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 strategies, 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.
Provide effective strategic and tactical leadership to support global regulatory plans including:
Develop and implement regulatory strategy and submission plans to support global pivotal 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
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.
The hiring pay range for this position is $165,000 - $213,000 per year based on skills, education, and experience relevant to the role. Other components of total compensation include a competitive equity grant at the time of hire (with additional annual grants, and grants upon promotion when applicable), and an annual bonus.
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.