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Regulatory Submissions Manager

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Location:
Australia , Sydney

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Category:
Research and Development

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Contract Type:
Not provided

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Salary:

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Job Description:

Regulatory Affairs Manager (FSP Global Pharma), Home-based in Australia. ICON plc is a world-leading healthcare intelligence and clinical research organization. We’re proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development. We are currently seeking a Manager, Regulatory Affairs, to join our diverse and dynamic team, embedded within a single sponsor model. As a Manager, Regulatory Affairs at ICON, you will be partnering with a forward‑thinking global pharmaceutical company known for its strong commitment to innovation and patient‑focused science. With a deep heritage in developing transformative therapies across areas of high unmet medical need, this organisation continues to push the boundaries of what is possible in modern medicine. You will have the opportunity to contribute to cutting‑edge research and development programs, supported by a culture that values curiosity, integrity, and continuous growth.

Job Responsibility:

  • Lead regulatory activities and submissions independently, with prior experience in areas such as CTA/IND/MAA
  • 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
What we offer:
  • 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, LifeWorks, offering 24-hour access to a global network of over 80,000 independent specialized 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, subsidized travel passes, health assessments, among others

Additional Information:

Job Posted:
February 13, 2026

Employment Type:
Fulltime
Work Type:
Remote work
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