Regulatory Affairs Expert – Senior Consultant

About the role

We are seeking an experienced Regulatory Affairs Expert to join our consulting team in Australia. The role combines regulatory expertise, project leadership and client management to support life‑science companies across medicines, biologics and medical devices.

Key responsibilities

• Lead end‑to‑end regulatory projects, from scoping through delivery and post‑submission client follow‑up.
• Manage client relationships, project resources, timelines and deliverables.
• Act as subject‑matter expert on Australian, New Zealand and JAPAC regulatory requirements.
• Support product development and regulatory strategies for medicines, biologicals and medical devices.
• Evaluate CMC, clinical and non‑clinical data for new registrations and lifecycle activities.
• Prepare, review and submit regulatory documentation, including safety updates and product information.
• Respond to regulatory authority queries and manage lifecycle maintenance activities.
• Mentor and develop project‑team members.

Required profile

• Undergraduate degree in pharmaceutical sciences or a related scientific discipline.
• Minimum 8 years of regulatory affairs experience, preferably in a commercial environment.
• Proven experience reviewing and presenting data for medicine dossiers.
• Strong knowledge of regulatory legislation, guidelines and procedures in Australia, New Zealand and the JAPAC region.
• Previous project‑management or consulting experience.
• Excellent client‑management, problem‑solving and communication skills.
• Fluent English; willingness to travel as required.

Required skills

• Regulatory submission preparation
• Regulatory documentation review
• Regulatory strategy development
• Project management
• Knowledge of Australian, New Zealand and JAPAC regulatory frameworks