Senior Regulatory Affairs Consultant, Life Sciences

Groupe ProductLife; Australia; Hybrid; AUD 120,000 - 170,000; Full time

Job summary

Groupe ProductLife in Australia seeks a Regulatory Affairs Expert / Senior Consultant to manage complex regulatory projects and provide strategic and technical guidance to life sciences clients.

This senior role combines regulatory expertise, project leadership, client management, submission delivery, and team mentoring, with focus on Australian requirements and local client management.

Qualifications

• Undergraduate qualification in pharmaceutical sciences or another relevant scientific discipline.
• Minimum 8 years of regulatory affairs experience, preferably in a commercial environment.

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.
• Review, critically evaluate, prepare, and submit regulatory documentation.
• Supervise, mentor, and develop project teams.

Skills

Regulatory strategy

Client management

Project leadership

Regulatory submissions

Regulatory communications

Education

Undergraduate qualification in pharmaceutical sciences or related field

Job description

Groupe ProductLife in Australia seeks a Regulatory Affairs Expert / Senior Consultant to manage complex regulatory projects and provide strategic and technical guidance to life sciences clients.

This senior role combines regulatory expertise, project leadership, client management, submission delivery, and team mentoring, with focus on Australian requirements and local client management.