Precision For Medicine

Regulatory Manager – Clinical Trials

Precision For Medicine

full-time

Posted on:

Location Type: Remote

Location: Hungary

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Job Level

Senior

About the role

  • Provides regulatory guidance throughout the clinical development life cycle
  • Compile, coordinate and review applications to Regulatory Authorities including, but not limited to, CTA/IND, annual reports, routine amendments, scientific advice/regulatory authority meetings, orphan designations, paediatric planning, and marketing applications. Also provides strategic regulatory input as required
  • Develops and/or reviews documents intended for submission to the Regulatory Authorities and/or Ethics Committees to assure compliance with regulatory standards
  • Serve as representative of Global Regulatory Affairs at project team meetings with both external and internal customers
  • Works within a project team, and where necessary, leads project for the region or globally
  • Oversee and coordinate Regulatory Affairs Specialists to achieve submission targets for contracted programs
  • Maintenance of project plans, project trackers and regulatory intelligence tools as it pertains to assigned responsibilities and to keep Regulatory Leadership updated.

Requirements

  • Bachelors degree, or equivalent experience, ideally in a scientific or healthcare discipline
  • 5 years Regulatory experience required for the Manager level and 7 years Regulatory experience required for the Senior Manager Regulatory level
  • Computer literacy (MS Office/ Office 365)
  • Fluent in English
Benefits
  • Precision for Medicine is not your typical CRO.
  • At Precision for Medicine we have brought together new technologies, expertise and operational scale to help the life sciences improve the speed, cost and success rate of bringing life-changing therapies to patients.
  • What sets us apart is the way we integrate clinical trial execution with deep scientific knowledge, laboratory expertise and advanced data sciences.
  • We have a strong focus on Oncology and Rare Disease.
Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills & Tools
regulatory guidanceregulatory submissionscompliance assuranceproject managementregulatory intelligence
Soft Skills
leadershipcommunicationcoordinationstrategic input