Seagen
Senior Manager, Regulatory Affairs 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!
Position Summary
The Sr. Manager, Regulatory CMC supports a senior regulatory professional by executing against the global regulatory plan for one or more products. This position represents Regulatory on cross-functional teams and leads the development and preparation of regulatory documentation to regulatory authorities.
Principal Responsibilities:
- Develop integrated regulatory plans that deliver against strategic objectives, maintain compliance, and protect patients
- Ensure receipt of timely and actionable regulatory authority feedback around key issues and program milestones, by defining the strategy and content to support agency interactions
- Function as primary liaison with regulatory authorities for Quality topics for commercial and clinical ex-U.S., including providing complete and timely responses to regulatory authority requests for information
- Assess regulatory program risks for likelihood and impact; establish mitigation strategies
- Oversee the planning and preparation of submissions to regulatory authorities, related to IND, IMPD, CTA, marketing applications and amendments
- Advise on regulatory requirements, expected outcomes, and changes to regulatory landscape
Qualifications:
- Bachelor's degree in scientific discipline and a minimum of 6 years regulatory experience; advanced degree desirable
- Biologic product experience strongly preferred
- Strong knowledge and understanding of the drug development process and regional regulatory requirements
- Experience interacting with regulatory authorities
- 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
- 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
- Proactively seeks out and recommends process improvements
- Enjoys working in a fast-paced, environment
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 $136,000 - $176,000 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 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.
Apply:
Seagen
Seagen is an Equal Opportunity Employer
Submitted: 11/10/2023
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