Seagen

Manager Regulatory Affairs

Development - Bothell, Washington

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 Regulatory Affairs Manager will report to and support the Global Regulatory Lead for a marketed product by executing against the global regulatory plan. This position will represent Regulatory on cross-functional teams and manage the development and preparation of regulatory documentation to regulatory authorities.

Responsibilities:

Provide effective strategic and tactical regulatory support for US/Rest of World regulatory submissions and maintenance activities, including:

• Lead the preparation of regulatory submissions including Clinical Trial Applications (CTAs), routine IND submissions, supplemental marketing applications, and routine reports.
• Manage the development and review of responses to health authority queries in a timely manner.
• Represent regulatory in cross-functional teams and communicate regulatory requirements to ensure optimal execution of the regulatory strategy.
• Develop and implement regulatory strategies to meet project deliverables and mitigate potential regulatory risks.
• Research relevant regulatory precedents to bring innovative approaches to the cross‑functional team and maintain knowledge of the regulatory landscape to pro-actively assess impact of changes on the commercial program.
• Maintain effective archiving and submissions/approvals tracking records.
• Assist GRL to establish processes and participate in process improvement initiatives as required.

Qualifications:

• 5+ years of relevant experience in regulatory affairs with drug or therapeutic biologic products or equivalent.
• Experience in the preparation/submission of regulatory documentation to support all regulatory submissions throughout product lifecycle.
• BS in a life sciences discipline; advance degree preferred but not required.
• 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 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, environment.
• Ability to work in Bothell, WA, Seattle, WA, or West Coast locations.

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 $113,000 to $146,000 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.

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: 01/06/2023