Regulatory Affairs Specialist APAC Submissions & Lifecycle

Groupe ProductLife; Australia; Hybrid; AUD 85,000 - 110,000; Full time

Job summary

Groupe ProductLife is seeking a Regulatory Affairs Officer / Associate Consultant based in Australia to support regulatory activities across Australia, New Zealand, and the JAPAC region. You will help with submissions, registrations, lifecycle maintenance, and regulatory interactions with authorities such as the TGA and Medsafe.

The role requires an undergraduate qualification in pharmaceutical sciences and at least three years of relevant regulatory/quality experience, with strong communication

Qualifications

• Bachelor-level qualification in pharmaceutical sciences or related field.
• Minimum of three years in Australian and New Zealand regulatory affairs or quality roles.
• Strong knowledge of TGA and Medsafe regulations and procedures.
• Excellent written and verbal communication skills.
• Ability to handle confidential information and meet deadlines.

Responsibilities

• Prepare and submit regulatory applications, dossiers, and compliance docs.
• Assist with registration and listing of pharmaceuticals, biologics and devices.
• Review regulatory dossiers for TGA and Medsafe submissions.
• Respond to questions from regulatory authorities as needed.
• Maintain lifecycle registrations and listings; prepare GMP clearance apps.
• Draft, review and update quality documentation.
• Support project and client management activities and proposals.
• Collaborate with cross-functional teams to ensure compliance.

Skills

Regulatory affairs

Project management

Communication

Education

Undergraduate qualification in pharmaceutical sciences

Job description

Groupe ProductLife is seeking a Regulatory Affairs Officer / Associate Consultant based in Australia to support regulatory activities across Australia, New Zealand, and the JAPAC region. You will help with submissions, registrations, lifecycle maintenance, and regulatory interactions with authorities such as the TGA and Medsafe.

The role requires an undergraduate qualification in pharmaceutical sciences and at least three years of relevant regulatory/quality experience, with strong communication