Seagen

Associate Director Regulatory Policy and Intelligence (Remote)

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 Policy & Intelligence, will be responsible for conducting 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 the development and maintenance of knowledge management processes and systems to maximize impact of regulatory intelligence on product strategy.

Principal Responsibilities:

• Supports the Regulatory Science team in providing up-to-date regulatory intelligence including responses to Ad hoc requests, which will inform regulatory strategy for drug development
• Defines and oversees the standardization and implementation of systems/processes to monitor the regulatory environment for changes that may have an impact on Seagen’s products and company goals
• Oversees the strategic assessment of external regulatory changes and works with subject matter experts internally, to drive and/or support impact analyses and ensure appropriate action(s) that mitigate risks to product development, authorization, and commercialization
• Anticipates changes in the regulatory environment and identifies opportunities to influence change
• Ensures effective communication of evolving regulatory expectations and requirements and the organization’s regulatory readiness activities to relevant leadership and governance bodies
• Collaboratively develops and maintains knowledge management strategies related to regulatory intelligence
• Identifies strategic opportunities and ensure organizational contribution to and participation on pertinent committees and other regulatory forums
• Manages trade association and consortium engagements; acts as Seagen representative to trade and industry organizations in support of business needs

Qualifications:

• 7-10 years’ experience in life sciences including 5+ years’ experience in regulatory affairs, preferably in regulatory strategy or intelligence. Oncology experience desirable
• Deep understanding of European regulations and guidance governing drugs and biologics in all phases of development, including post-marketing, with a good understanding of basic regulatory requirements in Canada, US and emerging markets
• 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

Location:

• (Remote) Preference for candidates located within the Eastern Time Zone as this role will be supporting US and EU business.

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.

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