Regulatory Affairs Expert / Senior Consultant

We are looking for an experienced Regulatory Affairs Expert / Senior Consultant to manage complex regulatory projects and provide strategic and technical guidance to life sciences clients.

This is a senior consulting position combining regulatory expertise, project leadership, client management, regulatory submission delivery, and team mentoring. The position must be based in Australia due to its focus on Australian regulatory requirements and direct local client management.

• Lead regulatory projects from initial scoping through delivery and client follow-up.

• Manage client relationships, project resources, timelines, and deliverables.

• Act as a regulatory subject-matter expert.

• Support product development and regulatory strategies for medicines, biologicals, and medical devices.

• Evaluate CMC, clinical, and non-clinical evidence supporting new registrations and lifecycle activities.

• Review, critically evaluate, prepare, and submit regulatory documentation.

• Review and perform quality control of regulatory, quality, and compliance documentation.

• Support literature-based submissions, including associated overviews and summaries.

• Assist clients with responses to regulatory authority questions.

• Manage lifecycle maintenance activities for registrations, listings, and inclusions.

• Prepare and submit safety-related updates to Product Information documents.

• Deliver regulatory submissions, reports, presentations, and strategic recommendations.

• Participate in meetings with clients and regulatory authorities.

• Supervise, mentor, and develop members of project teams.

• Undergraduate qualification in pharmaceutical sciences or another relevant scientific discipline.

• Minimum 8 years of regulatory affairs experience, preferably in a commercial environment.

• Experience reviewing, critically evaluating, and presenting data for medicine dossiers.

• Good knowledge of regulatory legislation, guidelines, and procedures in Australia, New Zealand, and the JAPAC region.

• Previous project-management and/or consulting experience.

• Strong client-management, problem-solving, and communication skills.

• Ability to manage complex and confidential information.

• Willingness to travel when required.

• Postgraduate qualification in a relevant discipline would be an advantage.

• Fluent English.