Sr. Manager, Regulatory Affairs

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POST DATE 9/8/2016
END DATE 10/9/2016

Seattle Genetics, Inc. Bothell, WA

Company
Seattle Genetics, Inc.
Job Classification
Full Time
Company Ref #
360713
AJE Ref #
576116179
Location
Bothell, WA
Experience
Entry Level (0 - 2 years)
Job Type
Regular

JOB DESCRIPTION

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p span style="font-family:verdana,geneva,sans-serif;" span style="font-size: 14px;" Summary: /span /span /p p span style="font-family:verdana,geneva,sans-serif;" span style="font-size: 14px;" Reporting to the Executive Director, Regulatory Affairs, the Sr. Manager will contribute to the development and execution of an effective registrational strategy for an investigational product and/or additional indications for marketed products. The successful candidate will serve as a regulatory contact within an internal matrixed team environment, as well as with health authorities and corporate partners. /span /span /p p /p p span style="font-family:verdana,geneva,sans-serif;" span style="font-size: 14px;" Responsibilities: /span /span /p ul li span style="font-family:verdana,geneva,sans-serif;" span style="font-size: 14px;" Develop integrated regulatory plans that deliver against strategic objectives, maintain compliance, and protect patients /span /span /li li span style="font-family:verdana,geneva,sans-serif;" span style="font-size: 14px;" Ensure receipt of timely and actionable health authority feedback around key issues and program milestones, by defining the strategy and content to support agency interactions /span /span /li li span style="font-family:verdana,geneva,sans-serif;" span style="font-size: 14px;" Function as primary liaison with health authorities, including providing complete and timely responses to health authority requests for information /span /span /li li span style="font-family:verdana,geneva,sans-serif;" span style="font-size: 14px;" Assess regulatory program risks for likelihood and impact; establish mitigation strategies /span /span /li li span style="font-family:verdana,geneva,sans-serif;" span style="font-size: 14px;" Support product labeling efforts from inception to final negotiation /span /span /li li span style="font-family:verdana,geneva,sans-serif;" span style="font-size: 14px;" Oversee the planning and preparation of submissions to regulatory authorities, both related to IND maintenance and marketing authorization /span /span /li li span style="font-family:verdana,geneva,sans-serif;" span style="font-size: 14px;" Advise on regulatory requirements, expected outcomes, and changes to landscape /span /span /li /ul p /p