Regulatory Medical Officer MO3 - Clinical Data Evaluator

Hudson Global, Inc.; Canberra; On-site; AUD 140,000 - 190,000; Full time

Benefits offered by this job

Casual loading

Job summary

Hudson Global, Inc. invites experienced Medical Practitioners to join the Clinical Evaluation Section as MO3 Evaluators.

In this non-clinical role, you will evaluate complex clinical data and pharmacological evidence to support the approval and registration of prescription medicines on the national register. You will collaborate with multidisciplinary teams, synthesize findings into regulatory reports, and contribute to post-market review processes while ensuring compliance with Australian

Qualifications

• Recognized medical degree (MBBS or equivalent).
• Current, unrestricted registration as a Medical Practitioner with AHPRA.
• Australian Citizenship is essential.

Responsibilities

• Undertake comprehensive, evidence-based evaluations of complex clinical data and scientific dossiers submitted for prescription medicine approvals and variations.
• Formulate clear, defensible clinical assessments and risk-benefit analyses to inform high-level regulatory decisions.
• Provide expert clinical and scientific advice on safety, therapeutic efficacy, and quality.
• Collaborate with multi-disciplinary scientific teams, external expert committees, and regulatory decision-makers to meet national health standards and statutory timeframes.
• Contribute to continuous improvement in regulatory processes and the ongoing post-market review of therapeutic products.

Skills

Analytical thinking

Written communication

Regulatory knowledge

Education

MBBS or equivalent

Job description

Hudson Global, Inc. invites experienced Medical Practitioners to join the Clinical Evaluation Section as MO3 Evaluators.

In this non-clinical role, you will evaluate complex clinical data and pharmacological evidence to support the approval and registration of prescription medicines on the national register. You will collaborate with multidisciplinary teams, synthesize findings into regulatory reports, and contribute to post-market review processes while ensuring compliance with Australian