Regulatory Affairs Project Expert

ProductLife Group; Melbourne; Presencial; AUD 150.000 - 230.000; Jornada completa

Descripción de la vacante

ProductLife Group in Australia is seeking an experienced Regulatory Affairs Expert / Senior Consultant to manage complex regulatory projects and provide strategic guidance to life sciences clients. Based in Australia, the role combines regulatory expertise, project leadership, and client management, delivering submissions and lifecycle activities for medicines, biologics, and medical devices.

You will mentor teams, review technical data, and interact with regulators to shape registrations and

Formación

• Undergraduate qualification in pharmaceutical sciences or equivalent.
• Minimum 8 years of regulatory affairs experience in a commercial setting.
• Experience reviewing and presenting data for medicine dossiers.
• Strong knowledge of regulatory legislation in Australia, New Zealand, and JAPAC.
• Previous project-management or consulting experience.
• Excellent client-management, problem-solving and communication skills.
• Ability to handle confidential information.
• Willingness to travel as required.
• Fluent English; postgraduate qualification is an advantage.

Responsabilidades

• Lead regulatory projects from scoping through delivery and client follow-up.
• Manage client relationships, 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 for registrations and lifecycle activities.
• Prepare and submit regulatory documentation.
• Review and QC regulatory, quality, and compliance documents.
• Assist clients with responses to regulatory authority questions.
• Manage lifecycle maintenance for registrations, listings, and inclusions.
• Deliver regulatory submissions, reports, presentations, and strategic recommendations.
• Participate in meetings with clients and authorities.
• Supervise and mentor project team members.

Conocimientos

Regulatory affairs

Project leadership

Client management

Strategic guidance

Educación

Bachelor's degree in pharmaceutical sciences

Postgraduate qualification

Descripción del empleo

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, 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.