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Manager, CMC Strategy

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POST DATE 9/15/2016
END DATE 10/16/2016

Seattle Genetics, Inc. Bothell, WA

Location
Bothell, WA
AJE Ref #
576179467
Job Classification
Full Time
Job Type
Regular
Company Ref #
360926
Experience
Entry Level (0 - 2 years)

JOB DESCRIPTION

Seattle Genetics is seeking a highly motivated individual to provide strategic guidance and functional expertise in the area of CMC Regulatory strategy and submission management across a range of programs, technology platforms, and regional jurisdictions. The successful candidate will draw from a demonstrated basis in CMC Regulatory, in order to contribute to the successful and efficient progression of development programs towards market approval and provide ongoing lifecycle support for a globally marketed commercial product. This is an evolving role for a well-qualified and motivated individual with strong experience in CMC Regulatory.

Responsibilities:
Lead the development of stage-specific regulatory content, including marketing applications for US, Europe, Canada and selected global markets, with an eye towards sound product lifecycle principles
Charter and manage submission teams through all stages of submission execution, leading to delivery of high-quality, on-time CMC Regulatory submissions
Contribute to effective planning and CMC Writing Team resource allocation to support a range of programs and supporting submissions
Interpret harmonized and regional regulatory guidelines in order to drive the refinement of quality systems, where they have regulatory and/or submission elements
Communicate project plans, progress, and issues to TOPS senior management and governance bodies
Foster a collaborative environment and contribute to a positive, dynamic, high-energy organization