Precision For Medicine

Regulatory Manager – Senior

Precision For Medicine

full-time

Posted on:

Location Type: Remote

Location: Slovakia

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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.
  • 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
  • Informed knowledge of all aspects of the drug development process inclusive of regulatory milestones and specialized knowledge of regulatory activities for at least one major region (EU, US) including but not limited to submissions to Regulatory Authorities, including INDs/CTAs and amendments, Scientific Advice Procedures, and post-approval submissions.
Benefits
  • Competitive salary
  • Flexible working hours
  • Professional development budget
  • Home office setup allowance
  • Global team events
Applicant Tracking System Keywords

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

Hard Skills & Tools
regulatory guidanceregulatory submissionsregulatory complianceproject managementregulatory intelligencedocument reviewclinical developmentdrug development processscientific advice proceduressubmission targets
Soft Skills
leadershipcommunicationcoordinationteamworkinterpersonal skills