Regulatory Affairs Project Expert

Commercial Eyes (CCE); Melbourne; Hybrid; AUD 120,000 - 160,000; Full time

Benefits offered by this job

Hybrid & flexible working

Job summary

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.

Responsibilities

• 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.

Skills

Client management

Problem solving

Communication skills

Education

Bachelor's degree in pharmaceutical sciences or relevant scientific discipline

Job description

Make a meaningful impact on global healthcare — and grow your career while doing it.

At ProductLife Group, you’ll join an innovative, forward‑thinking team operating across the world to shape the future of life sciences through expertise, collaboration, and purpose‑driven work.

Job Description

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.

Key responsibilities

• 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.

Requirements

• 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, NewZealand, 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.

PLG partners with Life Sciences innovators to bring new medicines and technologies to patients, faster.

Join a fast-growing, entrepreneurial company where your expertise makes a difference from day one.

Culture

• A path for every career stage, from graduate to senior expert
• Exciting, high‑impact projects with leading life sciences clients
• International by design
• Hybrid & flexible working
• Continuous learning
• An inclusive & diverse culture