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We are searching for a remote Associate Director of Regulatory Affairs to join an industry leading pharmaceutical company in St. Louis, MO. The Associate Director of Regulatory Affairs will be responsible for applicable regulatory affairs activities related to managing and implementing tracking systems, preparing submissions and new and existing dossiers. The primary role of this position will be on new submissions and products already being tested in clinical and non-clinical studies.
Requirements of the Associate Director Regulatory Affairs:
  • BS in chemistry, biology, pharmacy or other relevant life science.
  • Minimum 7 years experience managing regulatory activities in a regulatory affairs position in the pharmaceutical industry.
  • 2+ years experience hands on team management experience.
  • Demonstrated experience leading successful new project submission efforts through strategy, compilation, and submission.
  • Experience authoring non-clinical studies and target product profiles as well as reviewing clinical protocols and summary reports.
Responsibilities of the Associate Director of Regulatory Affairs:
  • Manage projects and submissions as delegated.
  • Review documentation for regulatory submissions and provide necessary input for revisions as needed.
  • Define target product profile and build compliant drug and device “approvable” dossiers and registration.
  • Oversee and maintain compliance database for tracking project deliverables for new submissions and RA compliance.
  • Devise and implement regulatory affairs policies, procedures, practices and strategies in alignment with regulatory requirements.
  • Liaise between global business units and regional regulatory affairs staff.
  • Communicate regulatory governmental policy changes to management and provide plans for complying with new requirements. Recommend strategies based on current registration requirements and industry standards.
  • Mentor regulatory affairs staff.
Occupational Category: 11-9199.01 Regulatory Affairs Managers
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Application Instructions: Please apply using the form or send your resume to Debbie Winkelbauer.