Senior Regulatory Affairs Lead - Global Life Sciences

Commercial Eyes (CCE); Melbourne; Hybride; AUD 120 000 - 160 000; Plein temps

Avantages offerts par ce poste

Hybrid & flexible working

Résumé du poste

ProductLife Group is seeking an experienced Regulatory Affairs Expert / Senior Consultant to drive complex regulatory projects and guide life sciences clients in Australia. The role combines regulatory leadership, client management, and submission delivery with team mentoring in a hybrid environment.

You will advise on medicines, biologicals and medical devices, review data for dossiers, and manage lifecycle activities while collaborating with regulators and stakeholders across APAC.

Qualifications

• Undergraduate qualification in pharmaceutical sciences or another relevant scientific discipline.
• Minimum 8 years of regulatory affairs experience, preferably in a commercial environment.
• Experience reviewing and presenting data for medicine dossiers.

Responsabilités

• Lead regulatory projects from scoping through delivery and client follow-up.
• Manage client relationships, resources, timelines and deliverables.
• Act as regulatory subject-matter expert for medicines, biologicals and devices.
• Submit regulatory documentation and perform quality control.
• Provide strategic guidance and lifecycle management support.

Connaissances

Client management

Problem solving

Communication skills

Formation

Bachelor's degree in pharmaceutical sciences or relevant scientific discipline

Description du poste

ProductLife Group is seeking an experienced Regulatory Affairs Expert / Senior Consultant to drive complex regulatory projects and guide life sciences clients in Australia. The role combines regulatory leadership, client management, and submission delivery with team mentoring in a hybrid environment.

You will advise on medicines, biologicals and medical devices, review data for dossiers, and manage lifecycle activities while collaborating with regulators and stakeholders across APAC.