Seagen

Associate Director Regulatory Intelligence

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 Intelligence, will conduct regulatory intelligence gathering, consolidation, and communication activities to support global product teams. They will support external regulatory intelligence and advocacy activities as an engaged member of trade and professional associations and be responsible for developing and maintaining knowledge management practices to maximize the impact of actionable regulatory intelligence on product strategy.

Principal Responsibilities:

• Supports US & International Regulatory Science teams in providing up-to-date actionable intelligence, proactively and upon request, which will inform regulatory strategy for new drug development in early-stage, late-stage, and life-cycle management settings.
• Masters the use of intelligence-gathering tools, databases, and internet-based information sources in the context of oncology drug development and regulatory science research.
• Oversees the internal communication of new health authority changes and consults with subject matter experts across the organization to establish and maintain their impact assessment programs.
• Collaboratively develops and maintains knowledge management strategies related to regulatory intelligence, including using IT tools, facilitating working groups and educational forums, and creating team intelligence-sharing practices.
• Anticipates changes in the external regulatory environment and identifies educational- or policy-related opportunities to participate in public commenting, workshops, consortiums, working groups, or trade associations.
• Coordinates and reports on trade association and consortium engagements across functions supporting new drug development.

Qualifications:

• A minimum of 5 years related regulatory experience, preferably in regulatory strategy or intelligence. Oncology experience is desirable
• Experience in US, Canada, and Europe preferred
• Deep understanding of health authority websites and public information sources, including regulations, guidance and policies governing drugs and biologics in all phases of development
• Excellent collaboration and relationship-building skills
• Outstanding written and oral communication skills
• Proven ability to work with a high level of integrity, accuracy, and attention to detail
• 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 thorough understanding of local compliance, as well as a sound ethical approach to business

Education:

• Bachelor’s degree or equivalent in data science or the life sciences. BA/BS accepted based on experience. Advanced degree preferred.

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.

The hiring pay range for this position is $162,000 to $209,000 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.

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: 01/13/2023