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Manager, Regulatory Affairs

Seattle Genetics, Inc.

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Location:
Bothell, WA
Posted Date:
6/23/2014
Position Type:
Full time
Job Code:
1404BH-01
Salary:
Required Education:
High school or equivalent
Areas of Expertise Desired:

Job Description

The primary purpose of this role is to:
•   Provide regulatory support to assigned drug development teams to assure successful and timely registration of Seattle Genetics drug products
•   Oversee development, preparation and submission of regulatory documentation to global regulatory authorities and communicate regulatory strategy and policy throughout the drug development process
•   Ensure that the quality and content of submissions will lead to successful and timely approval of regulatory applications

Specific responsibilities include:
•   Provide tactical and strategic regulatory representation on assigned project teams
•   Develop, prepare and review regulatory submissions for assigned projects
•   Communicate regulatory policy to internal drug development teams and provide clarity on regulatory expectations and timelines
•   Prepare, maintain and/or coordinate global regulatory submissions (INDs, CTAs, marketing applications) in accordance with applicable regulations
•   Serve as primary contact to FDA (and other relevant regulatory authorities) for routine communications in support of submissions
•   Assist in preparation for and participate in FDA (and other relevant regulatory authority) face-to-face and teleconference meetings
•   Work with contract research organizations for ex-US regulatory submissions

Requirements

Requirements:
•   Bachelor’s Degree in scientific discipline or equivalent; advanced degree desirable
•   Two to five (2-5) years of relevant experience in regulatory affairs with drug or therapeutic biologic products; experience with companion diagnostics and/or international clinical trials is a plus
•   Excellent communication skills, verbal and written
•   Excellent interpersonal skills and leadership potential
•   Excellent knowledge of regulations
•   Computer literate
•   Ability to work with minimal supervision
•   Able to travel for face-to-face meetings with regulatory authorities

Seattle Genetics is an Equal Opportunity Employer

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