Global Regulatory Lead for Complex Clinical Trials

Indero; Australia; Remote; AUD 120,000 - 160,000; Full time

Benefits offered by this job

Flexible work schedule

Permanent full-time position

Complete benefits (medical, dental, RR

Professional development opportunities

Job summary

Indero in Australia seeks a Senior Regulatory Affairs Specialist to lead regulatory activities for clinical trials and large multinational submissions. You will oversee sponsor-facing regulatory deliverables and mentor junior colleagues.

You will coordinate timelines, prepare country packages, review core documents, and contribute to process improvements while ensuring compliance with global regulatory requirements, including EU-CTR. Fluent English is required; additional languages are welcome.

Qualifications

• Bachelor's degree in a scientific discipline; Regulatory Affairs is an asset.
• 3–5 years in clinical regulatory affairs (pharma/biotech/CRO).
• Experience preparing IRB/IEC packages and CTAs.
• Strong knowledge of global regulatory requirements; EU-CTR experience.
• Fluency in English; additional languages are a plus.
• Ability to lead global submissions and coordinate timelines.

Responsibilities

• Coordinates regulatory timelines and deadlines for all assigned projects planned for RA and EC submissions.
• Lead global/multinational submissions of complex large clinical trials.
• Addresses sponsor queries related to regulatory and submission requirements.
• Prepares/reviews core packages and country packages for submission to RA in assigned countries.
• Peer review of documents and packages prepared by colleagues within regulatory team.
• Mentor to new or junior colleagues within regulatory team.

Skills

Regulatory submissions

Global regulatory leadership

Project coordination

English language

Education

Bachelor's degree in a scientific discipline

Job description

Indero in Australia seeks a Senior Regulatory Affairs Specialist to lead regulatory activities for clinical trials and large multinational submissions. You will oversee sponsor-facing regulatory deliverables and mentor junior colleagues.

You will coordinate timelines, prepare country packages, review core documents, and contribute to process improvements while ensuring compliance with global regulatory requirements, including EU-CTR. Fluent English is required; additional languages are welcome.