Senior Regulatory Affairs Project Lead — Hybrid AU

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

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.