Senior Regulatory Affairs Specialist

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 Pty Ltd (SCDC)

About us

Bringing innovative therapies to market is complex, and sponsors partner with Southern Clinical Development Consulting (SCDC) to get it right. We deliver tailored clinical research solutions from First-in-Human studies through to Phase 3 trials. We combine international experience with essential local regulatory knowledge, across demanding therapeutic areas including oncology, ophthalmology, cardiology, rare diseases, infectious diseases and immunology.

About the role

As our Senior Regulatory Affairs Specialist, you’ll lead regulatory strategy and submissions for sponsor products in Australia and New Zealand, working directly with the Therapeutic Goods Administration (TGA) and Medsafe. You’ll own submissions end to end, from strategy and dossier preparation through to agency meetings and approval, within your specialty area of regulatory CMC, nonclinical or clinical. Reporting to the Head of Regulatory Affairs, this is a client-facing role for an experienced regulatory professional who can deliver high-quality work to sharp turnaround times across multiple concurrent projects.

Key responsibilities

Regulatory strategy and advice

• Develop and advise on regulatory strategies for sponsor products seeking registration in Australia and New Zealand.
• Provide expert input in your specialty area, including gap analyses and regulatory risk assessments.
• Interpret TGA and Medsafe guidance and legislation, and advise clients and internal teams on its practical impact.
• Monitor regulatory changes and share relevant updates across the business.

Regulatory submissions

• Prepare, compile, review and lodge registration submissions (marketing applications) with the TGA and Medsafe, including new medicines, variations and responses to agency questions.
• Prepare and manage GMP clearance submissions for overseas manufacturers.
• Author and review CTD modules relevant to your specialty, ensuring scientific accuracy and compliance with agency requirements.
• Coordinate submission timelines and inputs from clients, manufacturers and internal teams to meet sharp turnaround times.

Agency interaction

• Plan, prepare briefing documents for, and attend pre-submission and other agency meetings with the TGA.
• Act as a primary point of contact with the TGA and Medsafe on assigned projects, managing correspondence and requests for information.

Client and project delivery

• Manage multiple concurrent regulatory projects, delivering to agreed scope, quality and timelines.
• Build strong client relationships and communicate complex regulatory matters clearly, verbally and in writing.
• Contribute to proposals, scopes of work and budget estimates for regulatory services.

Ways of working and continuous improvement

• Use modern tools, including generative AI, to improve the quality and speed of regulatory deliverables.
• Contribute to templates, SOPs and process improvements for the regulatory function.
• Mentor and review the work of junior regulatory staff as required.

Your profile

• A Bachelor of Science (Honours) in a biological or medical science discipline, or a Bachelor of Pharmacy (Honours) / Master of Pharmacy.
• At least 5 years’ regulatory affairs experience in Australia, with direct experience working with the TGA and Medsafe.
• Demonstrated experience with multiple registration submissions (marketing applications) to the TGA.
• Demonstrated experience preparing GMP clearance submissions.
• Experience preparing for and participating in agency meetings with the TGA.
• A specialty regulatory area: regulatory CMC, nonclinical or clinical.
• Excellent written and verbal English, with the ability to explain complex regulatory matters clearly to clients and agencies.
• Strong, practical proficiency with modern digital tools, including generative AI.

It’s a plus if you have

• A Master’s degree (MSc) or PhD in a biological or medical science discipline.
• Regulatory consultancy experience, delivering regulatory services across multiple sponsor clients.
• Proficiency in a second language.
• Experience with eCTD publishing and submission systems.

Why SCDC?

• Hybrid working, with the flexibility to be based in Melbourne, Sydney or Brisbane.
• End-to-end ownership of submissions, working directly with the TGA and Medsafe.
• Variety across multiple sponsor clients and products.
• Use of modern tools, including generative AI, in regulatory delivery.
• The opportunity to contribute to templates, SOPs and process improvements, and to mentor junior regulatory staff.
• Competitive salary plus superannuation.
• Laptop provided.

Working arrangements

This is a hybrid role. Peak workloads may arise around submission deadlines and agency timelines, and occasional travel may be required.

Applicants must be based in Australia and have working rights. Overseas applications will not be considered, and visa sponsorship is not available for this role.