Regulatory Affairs Manager - Remote

1w1 week ago

ICON plc

Sydney, AU · Full-time · A$140,000 – A$180,000

About this role

ICON plc is a world-leading healthcare intelligence and clinical research organization fostering an inclusive environment that drives innovation and excellence. We seek a Manager, Regulatory Affairs to join our diverse and dynamic team embedded within a single sponsor model. Partner with a forward-thinking global pharmaceutical company committed to innovation and patient-focused science.

Contribute to cutting-edge research and development programs in areas of high unmet medical need. Lead regulatory activities and submissions independently, including CTA/IND/MAA. Provide regulatory guidance to internal teams and participate in agency interactions.

Work collaboratively as part of a regulatory or cross-functional team, depending on project size and nature. Benefit from a culture that values curiosity, integrity, and continuous growth. Develop best practices within ICON Regulatory Affairs through insight into regulatory processes and guidelines.

Our success depends on the quality of our people, building a diverse culture that rewards high performance and nurtures talent. ICON offers benefits focused on well-being and work-life balance for you and your family. Visit our careers site to learn more about what we provide.

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

Responsibilities

Lead regulatory activities and submissions independently, with experience in 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 insight of regulatory processes and guidelines
Work collaboratively as part of a regulatory or cross-functional team, depending on project size and nature

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
Global Employee Assistance Programme, TELUS Health, offering 24-hour access to a global network of specialised professionals
Life assurance
Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidised travel passes, health assessments