Seagen

Manager Regulatory Affairs CMC

Description

Summary

Now is the time to explore Seagen for your next career move in the vibrant west coast cities of Seattle and San Francisco. We are currently seeking a Manager of Regulatory CMC located at either our South San Francisco, CA site or our corporate headquarters just north of Seattle, WA. At Seagen, you have the opportunity to make a meaningful difference in cancer patients’ lives by working together in a culture of innovation, scientific excellence, teamwork, integrity and mutual respect to advance transformative therapies from discovery to the global marketplace.

Role

The Regulatory CMC Manager supports a senior regulatory CMC professional by executing against the global regulatory CMC plan for one or more products. This position represents Regulatory on cross-functional teams and manages the development and preparation of regulatory documentation to regulatory authorities. The successful candidate will plan, prepare, and gain appropriate internal review and approval of CMC-related regulatory documentation to ensure its suitability for submission to health authorities. They will provide regulatory guidance to biologics, antibody-drug conjugate, small molecule and novel modality project teams to ensure compliance with relevant regulations, guidelines, and industry standards and also support Regulatory systems, such as change control and knowledge management.

Our ideal new colleague is a good team player, dynamic, optimistic, accurate, result-oriented, hard-working and creative. They are skilled at developing interpersonal relationships and demonstrate open, clear, persuasive communication with internal and partner teams. They strive for the best performance and are curious with a willingness to learn.

Responsibilities:

• Proactively manage Chemistry, Manufacturing & Controls (CMC) aspects of one or more products in early-to-late development through interaction with multiple functions to create high quality regulatory submissions that support product development strategy and ensure complete CMC content that meets current regional requirements
• Evaluate proposed manufacturing changes for global impact to ongoing and existing filings, and providing strategic regulatory guidance for optimal implementation of changes
• Research and interpret global CMC regulations and provide regulatory guidance to the Quality, Manufacturing, Process Development and other functional groups within the Technical Operations organization
• Represent the Regulatory Affairs CMC function on assigned cross-functional project teams
• Manage interactions with global regulatory authorities for assigned projects to ensure acceptance, rapid review and approval of marketing applications, supplements/variations, clinical trial applications and other submissions which present CMC information
• Develop excellent relationships with internal functional groups, contract manufacturing organizations, and corporate partners

Qualifications:

• BA/BS degree in life sciences in chemistry, molecular biology, immunology or similar is desirable. Ph.D. is preferred
• At least 3 years of experience in Regulatory Affairs
• At least 5 years in a related discipline in the pharmaceutical or biotechnology industry (preferably with exposure to cGMP and both development and commercial phases of product lifecycle)
• Strong working knowledge of U.S. and EU regulatory requirements for biologics and small molecules, with preference for antibody drug conjugates
• Experience in preparation of clinical trial applications, marketing applications, supplements, and/or Variations for pharmaceutical or biologic products in the U.S., Canada and Europe using eCTD format
• Experience in assessing post-marketing changes
• Outstanding interpersonal and communication (written and verbal) skills is required
• Demonstrated ability to work within a cross-functional matrix team environment, such as cross-functional groups in Quality and Manufacturing, and including contractors, partners, and CRO’s in the international markets
• Highly organized, independent, self-motivated and able to meet deadlines
• Proficiency with standard software programs (e.g., Word)

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.

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Seagen

Seagen is an Equal Opportunity Employer

Submitted: 02/05/2021