Regulatory Affairs Project Expert

PLG; Melbourne; Hybrid; AUD 180,000 - 240,000; Full time

Job summary

ProductLife Group in Melbourne is seeking an experienced Regulatory Affairs Expert / Senior Consultant to oversee complex regulatory projects across medicines, biologics, and medical devices. The role blends regulatory strategy, project leadership, and client management in a senior consulting capacity.

Based in Australia, you will manage scoping to delivery, review regulatory submissions, mentor teams, and engage with authorities to support lifecycle activities.

Qualifications

• Undergraduate qualification in pharmaceutical sciences or a relevant scientific discipline.
• Minimum 8 years of regulatory affairs experience, preferably in a commercial environment.
• Excellent knowledge of regulatory legislation for Australia, New Zealand and JAPAC.
• Postgraduate qualification would be an advantage.

Responsibilities

• Lead regulatory projects from scoping through delivery and client follow-up.
• Manage client relationships, project resources, timelines, and deliverables.
• Act as a regulatory subject-matter expert and mentor for teams.
• Support product development and regulatory strategies for medicines, biologics, and medical devices.
• Review, critically evaluate, and submit regulatory documentation.
• Engage with regulatory authorities and support lifecycle activities.

Skills

Client management

Communication skills

Problem solving

Education

Undergraduate degree in pharmaceutical sciences

Postgraduate qualification (advantage)

Job description

## Regulatory Affairs Project ExpertApply: Hybrid: Melbourne Co work: Full time: Posted 17 Days Ago: JR000024Make 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, 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.Ready to take the next step? Apply today and join a global, innovative team that’s shaping the future of life sciences and empowering people to make a real impact in healthcare.