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Regulatory Affairs Manager Full-time

at Piper Companies New York in New York (Published at 27-08-2022)

Piper Clinical is seeking a Regulatory Affairs Manager to join a global CRO in a fully remote capacity! The role prioritizes project management and is a permanent, direct placement opportunity.


Responsibilities for the Regulatory Affairs Manager include:

  • Supporting and managing client portfolios for Sponsors
  • Collaborating with cross-functional teams (such as Regulatory Writing, Regulatory Submissions, etc.) to execute projects and programs for Sponsors
  • Coordinating project start-up activities, track and report project status, maintain project documentation, submission timelines, and scopes of work
  • Serving as the primary point of contact for Sponsors and other regulatory personnel, ensuring client project needs are clearly communicated and promptly addressed
  • Maintaining project timelines with multiple regulatory submissions
  • Scheduling and leading internal & external project team meetings, preparing presentations, and developing meeting agendas
  • Reporting project metrics and performing project close-out activities
  • Attending clinical operations internal meetings as the representative for Regulatory Affairs


Qualifications for the Regulatory Affairs Manager include:

  • 5+ years of regulatory experience within a CRO or pharmaceutical company
  • Prior experience drafting and submitting reports for IND review is required
  • Bachelor?s degree in Life Sciences or similar field is required


Compensation for the Regulatory Affairs Manager includes:

  • Salary Range: approximately $120,000 - $180,000 annually, commensurate with experience
  • Full Benefits: Medical, Dental, 401k, Flex PTO, Equity, Stock Options


Keywords

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