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

Seagen is recruiting an opening for an Associate Director, Regulatory CMC to provide skilled support of one or more late phase development programs. The successful candidate works independently to develop and implement biologics regulatory strategy, ensuring timely preparation, review and submission of documentation to regulatory authorities while maintaining compliance with applicable regulatory requirements for fast-moving oncology programs. This position represents the regulatory function on multi-disciplinary teams and serves as a resource to team members for regulatory requirements to conduct global drug development activities for compounds in late phase and initial registration.

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
• Represents the Regulatory CMC function on cross-functional teams and communicates regulatory requirements to ensure optimal execution of the regulatory strategy for late phase and registration phase oncology products
• Identifies and assesses regulatory risks for the assigned program(s)
• Assesses the impact of proposed CMC changes on the program dossiers and ensures the appropriate submissions are filed to support implementation
• Serves as point of contact with regulatory authorities, as applicable
• Monitors and researches regulatory intelligence to bring innovative, compliant approaches to assigned program(s) and maintains 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 CMC experience; advanced degree desirable
• Late-stage development biologics Regulatory CMC experience required
• Demonstrated skills in preparation of registration dossiers for global submission required
• Knowledge and understanding of global regulations and guidelines
• Experience leading a cross-functional team to prepare and execute major regulatory authority interactions
• Excellent oral and written communication skills to effectively interface with all levels of management and departments within the company

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 $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.

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.

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Seagen

Seagen is an Equal Opportunity Employer

Submitted: 05/19/2023