Regulatory Affairs Specialist (Australia)

Role overview

This position is responsible for handling the daily workload and delivery of global regulatory affairs support. The role focuses on managing clinical trial submissions to Competent Authorities, Ethics Committees, and Regulatory Agencies, while also researching, reviewing, and reporting on relevant international regulations and requirements.

You will help build stakeholder-facing tools, prepare and process regulatory risk assessments, and work closely with other internal functions, sponsors, researchers, and regulatory bodies. The job also calls for maintaining high standards of quality and turnaround time in line with company, industry, and regulatory expectations. Depending on business needs, you may also mentor colleagues and contribute to performance feedback.

Unit management

• Oversee the everyday execution of regulatory services and workflows, including preparing filings, submissions, and revisions for projects, external vendors, and clinical locations.
• Carry out or support regulatory and safety reviews, develop regulatory tools and learning materials, and stay updated on clinical research regulations and best practices so changes can be communicated promptly to project leaders.

Client services

• Act as a regulatory affairs specialist for the business, offering guidance on regulatory, ethics, and pharmacovigilance matters to project stakeholders.
• Represent the unit in project meetings, help create education and regulatory tools, participate in reviews and audits, interact with clients to manage expectations, and liaise with regulatory, ethics, and government contacts. Where appropriate, respond to regulatory questions on the client’s behalf.

Regulatory strategy development

• Track updates in clinical research regulation and industry practice, then recommend, introduce, and maintain company regulatory approaches to help meet or exceed compliance standards as requirements evolve, working with other specialists such as safety and quality assurance when needed.
• Take part in specialized meetings and conferences to broaden expertise as required.

Project support

• Respond regularly to registration-related requests and partner with project teams to determine applicable regulatory requirements.
• Help prepare regulatory submissions and support documentation summaries.
• Ensure project and site files are created, updated, archived, revised, or disposed of according to project and regulatory rules, and make sure all stakeholders are properly informed and trained on the relevant obligations.

Qualifications

Applicants need at least an undergraduate degree and 4 to 6 years of relevant experience in clinical research or regulatory affairs. Strong knowledge of LATAM clinical trial regulations is required, along with fluency in written and spoken English and Spanish.

Working conditions

This is a home-based role. Accommodation for applicants with disabilities is available upon request.

AI-assisted hiring notice

The employer may use AI-based tools during parts of the hiring process, including resume review, application analysis, response assessment, and screening for possible inconsistencies or verification signals. These tools support the recruiting team but do not replace human judgment. Final hiring decisions are made by people. For details about how personal data is processed, candidates may contact the employer.