Senior Regulatory Affairs Specialist — Trials Australia

Jobgether; Australia; On-site; AUD 120,000 - 180,000; Full time

Benefits offered by this job

Permanent full-time

Flexible schedule

Medical/dental/vision coverage

RRSP benefits

Paid time off

Virtual clinic access

Transit rebates

Professional development

Collaborative environment

Job summary

Jobgether is seeking a Senior Regulatory Affairs Specialist based in Australia to lead regulatory activities for complex multinational clinical studies. You will be the regulatory contact for sponsors and project teams, guiding local submissions and ensuring compliance with local and international requirements.

The role emphasizes strategic regulatory leadership, collaboration across regions, mentorship of junior staff, and contributions to process improvements, regulatory intelligence, and

Qualifications

• Bachelor's degree or equivalent in a scientific discipline; RA qualification is an advantage.
• 3–5 years of clinical regulatory affairs experience in pharma, biotech, or CRO.
• Experience preparing IRB/IEC packages and CTAs.
• Strong understanding of global regulatory requirements across countries.
• Experience coordinating regulatory activities across Europe and APAC, including Australia/NZ.
• Fluent English with excellent written and verbal communication.
• Ability to manage multiple priorities in an international setting.

Responsibilities

• Coordinate timelines, milestones, and deadlines for regulatory authority (RA) and ethics committee (EC) submissions.
• Lead global and multinational submissions for complex trials, ensuring accuracy, consistency, and compliance.
• Respond to sponsor inquiries on regulatory requirements and procedures.
• Advise project teams on regulatory strategy with local submission guidance.
• Prepare and review core and country-specific submission packages.
• Mentor junior team members and support process improvements.
• Contribute to regulatory intelligence and audits.
• Review regulatory documents before release of investigational products.
• Develop country-specific clinical trial drug labeling.
• Participate in project kick-offs and client meetings.

Skills

Regulatory leadership

Regulatory affairs

Project coordination

Communication

Mentoring

Education

Bachelor's degree in a scientific discipline

Regulatory Affairs qualification (advantage)

Tools

IRB/IEC submissions

CTA submissions

EU-CTR knowledge

Job description

Jobgether is seeking a Senior Regulatory Affairs Specialist based in Australia to lead regulatory activities for complex multinational clinical studies. You will be the regulatory contact for sponsors and project teams, guiding local submissions and ensuring compliance with local and international requirements.

The role emphasizes strategic regulatory leadership, collaboration across regions, mentorship of junior staff, and contributions to process improvements, regulatory intelligence, and