About the role

This well regarded clinical research organisation on a mission to improve world health by expertly managing clinical trials that accelerate medical advancements. They are looking for an experienced Regulatory Submissions Specialist to join their team and play a central role in ensuring every trial run meets its regulatory and governance requirements from start to finish.
This is a role where your attention to detail, regulatory expertise, and collaborative nature will genuinely matter. You’ll be the go-to person for governance and regulatory submissions across the organisation; working closely with trial teams, investigators, and leadership to protect trial integrity and keep studies moving.

What you’ll be doing

• Acting as the primary contact for all governance and regulatory submission matters, including Ethics and Research Governance applications and post-approval reviews
• Maintaining and improving the submissions process in line with internal guidelines and regulatory requirements
• Leading the development of best-practice SOPs, policies, and training for regulatory submissions
• Identifying and managing documentation risk across trials, working closely with the Quality team
• Supporting the trial team during study start-up to ensure regulatory timelines are met
• Educating and advising investigators, coordinators, and other stakeholders on governance and submission requirements
• Driving continuous improvement through streamlined processes and optimal use of technology platforms

 
What we’re looking for

• 3+ years of clinical research experience with solid knowledge of Research Governance and Ethics processes
• Sound understanding of Medicines Australia, contracts, insurance, indemnity, and risk
• Tertiary qualifications in Nursing, Medicine, Science, or equivalent
• Excellent written and verbal communication skills with a sharp eye for detail
• Proficiency in Microsoft Office suite
• Australian Citizen or Permanent Resident

 
Who you are
You’re someone who thrives in a fast-paced environment, takes pride in accuracy, and brings a calm, organised approach when priorities shift. You’re proactive, resilient, and genuinely enjoy helping your colleagues navigate complex regulatory landscapes. You understand the bigger picture,  and how rigorous governance enables the kind of research that changes lives.

What’s on offer

• Competitive salary
• A collaborative, values-driven team culture
• Meaningful work at the intersection of science, regulation, and patient outcomes
• Opportunities for professional development and growth

How to Apply
Click apply if you fulfil the mandatory Skills and Experience above.
 
About Healthcare Professionals Group
Healthcare Professionals Group recruits all positions: executive, permanent, contracting/temp, at all levels, across all areas of healthcare - Pharmaceuticals, Biotechnology, Medical Technology and Clinical Care.

• Medical Affairs & Life Sciences Recruitment - Clinical Research, Market Access, Medical Affairs, Pharmacovigilance, Quality, Data Management, Regulatory Affairs, Scientific;
• Commercial Recruitment - Marketing, Sales, Analytics, Government and External Affairs;
• Business Operations & Infrastructure Recruitment - Administration, Customer Service, Engineering, Finance, Human Resources, IT, L&D, Legal, Manufacturing, Operations, Supply Chain, Warehouse;
• Clinical Care Recruitment - Allied Health, Aged Care, General Practice, Medical Imaging, Medical Management, Medical Specialties, Nursing.

For more job opportunities, visit www.hpgconnect.com.