Manager/Sr. Manager, Regulatory Operations - Bothell, WA | Biospace
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Manager/Sr. Manager, Regulatory Operations

Seattle Genetics, Inc.

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Location:
Bothell, WA
Posted Date:
7/24/2017
Position Type:
Full time
Job Code:
1985
Salary:
Required Education:
Bachelors Degree
Areas of Expertise Desired:

Job Description

Summary:
 
 Primary purpose of this role:

   
        
  • Ensure all electronic regulatory submissions are prepared within required ICH eCTD specifications and guidelines
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  • Manage the preparation of regulatory dossiers (IND, IMPD, BLA, NDS, MAA) and their amendments in eCTD format for submission to the applicable regulatory authority (FDA, HC, EMA) within required timeframes
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  • Develop/Maintain regulatory submission plans in partnership with Regulatory Science
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  • Develop/Maintain electronic submission processes and planning tools for the facilitation of orderly and timely regulatory submissions
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 Responsibilities:

   
        
  • Manage the preparation of individual regulatory dossiers and their amendments for electronic submission to the applicable regulatory authority in compliance with required eCTD specifications and guidelines, within agreed upon corporate timeframes
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  • Collaborate with Regulatory Science to ensure full and complete integration resulting in high quality and timely submissions to regulatory authorities
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  • Interface with personnel from appropriate functional groups (Clinical, Drug Safety, Medical Writing, CMC Technical Writing, Non-Clinical, Pharmacology, Biometrics, Data Management, Marketing, Program Management, etc.) to ensure seamless interactions between said groups and Regulatory Operations
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  • Create/Maintain current regulatory submission trackers
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  • Coach/Develop junior Regulatory Operations team members to maximize their contributions and personal growth
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Requirements


Qualifications:

  • Bachelor's degree or equivalent experience, preferably in a scientific discipline
  • 5-10+ years of experience in Regulatory Affairs/Regulatory Operations in the pharmaceutical/biotechnology industry
  • High level of technical expertise in electronic submission software
  • Thorough knowledge of electronic Common Technical Document submission requirements
  • Demonstrated ability to successfully interact with regulatory authorities on the technical aspects of electronic regulatory submissions
  • Self-organizing, self-directing, highly motivated with strong critical thinking and analytical skills
  • Excellent communication and team management skills

Seattle Genetics is an equal opportunity employer. All qualified applications will receive consideration for employment without regard to race, color, religion, sex, national origin, protected veteran status, or disability status.