Clinical Research Regulatory Affairs Director

4 weeks ago


Houston, United States BKOutlooks Full time
Job DescriptionJob Description

This is a remote position.

Clinical Research Regulatory Affairs Director - Direct Hire - US

US, home-based


Bachelor's degree in scientific discipline + 10-15yrs regulatory affairs experience in life science/clinical research + 8yrs people management experience


Negotiable Salary

(sponsorship not available)


Submit resume via www.bkoutlooks.com


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Job Responsibilities:

  • Responsible for leading team of regulatory affairs professionals
  • Provide expertise in interactions with regulatory agencies (such as FDA) and provide expertise in regulatory guidelines and requirements
  • Interact with various stakeholders, including writing team, subject matter experts, project leadership, and the Sponsor with a focus on high quality deliverables
  • Assist your team as needed in the development of regulatory submission strategies
  • Utilize expertise to create efficient workflows and timelines
  • Provide support to your team and utilize your expertise in regulatory writing to produce high quality documentation for regulatory submissions
  • Demonstrate strong project management skills to ensure on-time and high quality project delivery



Job Qualifications:

  • Degree in scientific or technical discipline (advanced degree preferred)
  • 10-15yrs experience related to regulatory affairs in the life sciences/clinical research
  • Previous experience at a CRO preferred
  • 8yrs experience in people management and leadership experience (within the clinical and non clinical regulatory functions)



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