Regulatory Submissions Manager at ICON plc

Sydney, New South Wales, Australia -

Full Time

Start Date

Immediate

Expiry Date

14 May, 26

Salary

0.0

Posted On

13 Feb, 26

Experience

5 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Regulatory Submissions, CTA, IND, MAA, Regulatory Guidance, Agency Interactions, Best Practices Development, Regulatory Processes, Regulatory Guidelines, Team Leadership, Cross-functional Teamwork

Industry

Biotechnology Research

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 Role: Manager Regulatory Affairs Location: Home-based in Australia 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. What you will be doing 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 Your profile 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 #LI-KA1 #LI-Remote What ICON can offer you: Our success depends on the quality of our people. That’s why we’ve made it a priority to build a diverse culture that rewards high performance and nurtures talent. In addition to your competitive salary, ICON offers a range of additional benefits. Our benefits are designed to be competitive within each country and are focused on well-being and work life balance opportunities for you and your family. Our benefits examples include: 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. Visit our careers site to read more about the benefits ICON offers. At ICON, inclusion & belonging are fundamental to our culture and values. We’re dedicated to providing an inclusive and accessible environment for all candidates. ICON is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know or submit a request here. Interested in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless – there’s every chance you’re exactly what we’re looking for here at ICON whether it is for this or other roles. Are you a current ICON Employee? Please click here to apply ICON is an award-winning workplace that enables you to make a difference to patients’ lives by being part of a world-class clinical research organisation that helps deliver new medicines & medical devices that are benefitting patients worldwide. You are also part of a diverse company that cares about our world and is dedicated to conducting business more sustainably and supporting the communities in which we live. If you’re as driven as we are, join us. You’ll be working in a great environment, with some of the brightest and the friendliest people in the sector, and you’ll be helping shape an industry. Didn’t find the role you were looking for? Even if the perfect role isn’t available right now, we’re always excited to connect with talented individuals. Register to our Talent Community to receive updates on roles that align with your career goals.

Responsibilities

The manager will lead regulatory activities and submissions independently, including areas such as CTA, IND, and MAA, while also providing essential regulatory guidance to internal teams. They will participate in agency interactions and contribute to developing best practices within ICON Regulatory Affairs.