Senior Regulatory Affairs Lead - Australia & NZ (Hybrid)

Southern Clinical Development Consulting; Melbourne; Hybrid; AUD 120,000 - 180,000; Full time

Benefits offered by this job

Laptop provided

Hybrid working

Competitive salary + superannuation

Job summary

Southern Clinical Development Consulting is seeking a Senior Regulatory Affairs Specialist to lead regulatory strategy and submissions for sponsor products in Australia and New Zealand. You will own end-to-end dossiers, interact with the TGA and Medsafe, and manage multiple projects with sharp turnaround times.

Reporting to the Head of Regulatory Affairs, you will mentor juniors, contribute to templates and SOPs, and leverage modern tools including generative AI to improve quality and speed of

Qualifications

• Bachelor-level science or pharmacy degree with honours.
• At least 5 years of regulatory affairs experience in Australia with TGA/Medsafe.
• Experience with multiple TGA registrations and GMP clearance submissions.
• Excellent written and verbal English; strong client communication.
• Experience with agency meetings and regulatory strategy.

Responsibilities

• Lead regulatory strategy and submissions for sponsor products in AU/NZ.
• Prepare, review and lodge TGA and Medsafe submissions.
• Coordinate agency meetings and manage timelines.
• Mentor junior staff and contribute to process improvements.
• Engage with clients and internal teams to manage regulatory risks.
• Utilize AI tools to enhance deliverables.

Skills

Regulatory strategy

Agency liaison

Regulatory submissions

English communication

Generative AI proficiency

Education

Bachelor of Science (Honours)

Bachelor/Master of Pharmacy (Honours)

Tools

eCTD publishing

Submission systems

Job description

Southern Clinical Development Consulting is seeking a Senior Regulatory Affairs Specialist to lead regulatory strategy and submissions for sponsor products in Australia and New Zealand. You will own end-to-end dossiers, interact with the TGA and Medsafe, and manage multiple projects with sharp turnaround times.

Reporting to the Head of Regulatory Affairs, you will mentor juniors, contribute to templates and SOPs, and leverage modern tools including generative AI to improve quality and speed of