Precision For Medicine

Regulatory Manager – Clinical Trials

Precision For Medicine

full-time

Posted on:

Location Type: Remote

Location: Romania

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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, pediatric planning, and marketing applications.
  • 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.
  • Assist in development of Regulatory Affairs Specialists and other operational area staff, as required.
  • Provide input, as required, into regulatory strategy and timeline development for new study opportunities.

Requirements

  • Bachelor’s 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.
  • Health insurance
  • Retirement plans
  • Paid time off
  • Flexible work arrangements
  • Professional development
  • Bonuses
  • Stock options
  • Wellness programs
Applicant Tracking System Keywords

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

Hard Skills & Tools
regulatory guidanceclinical developmentregulatory submissionsregulatory complianceproject managementregulatory strategyregulatory intelligence
Soft Skills
leadershipcommunicationcoordinationteamwork