ICON plc

Regulatory Submissions Manager – EU CTR

ICON plc

full-time

Posted on:

Location Type: Remote

Location: France

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About the role

  • Lead regulatory activities and submissions independently, with prior experience in areas such as CTA/IND/MAA EU CTR and UK-specific submissions essential experience here required
  • Management of activities associated with obtaining initial, amendment and other central authority approvals
  • Companion diagnostics, IVDR submissions, clinical performance studies experience would be beneficial
  • Oversee preparation of core regulatory packs.
  • Provide broad regulatory support across EU and UK requirements.
  • Provide regulatory guidance and efforts to internal teams
  • Participate in agency interactions and regulatory submissions
  • Contribute to developing best practices within ICON Regulatory Affairs through your insight of regulatory processes and guidelines
  • Work collaboratively as part of a regulatory or cross-functional team, depending on project size and nature

Requirements

  • Bachelor's degree in a scientific or healthcare-related field; advanced degree preferred
  • Minimum of 6 years of experience in regulatory affairs within the pharmaceutical or biotechnology industry
  • Prior experience with various regulatory submissions, including CTA/IND/MAA
  • Ability to lead internal teams and carry out regulatory activities independently
  • Strong understanding of global regulatory requirements and guidelines
Benefits
  • Various annual leave entitlements
  • A range of health insurance offerings to suit you and your family’s needs.
  • Competitive retirement planning offerings to maximize savings and plan with confidence for the years ahead.
  • Global Employee Assistance Programme, TELUS Health, offering 24-hour access to a global network of over 80,000 independent specialised professionals who are there to support you and your family’s well-being.
  • Life assurance
  • Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidised travel passes, health assessments, among others.
Applicant Tracking System Keywords

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

Hard Skills & Tools
regulatory submissionsCTAINDMAAIVDRclinical performance studiesregulatory guidanceregulatory processesregulatory approvalsregulatory packs
Soft Skills
leadershipcollaborationcommunicationinsightindependence
Certifications
Bachelor's degreeadvanced degree