CSL, a global biotech company, provides lifesaving products to patients in more than 100 countries. An exciting new opportunity has arisen in the CSL Seqirus APAC In-Licensing Regulatory Affairs team for an experienced regulatory affairs professional in the role of Principal Associate . Based in Melbourne, the Principal Associate supports product registrations and maintenance in Australia and New Zealand, as well as new product opportunities.

Responsibilities

- Work with the manager to develop regulatory strategies for new and existing products.
- Plan, prepare and submit high-quality applications in Australia/New Zealand, including new product applications (with manager) and variation applications (independently) and respond to agency questions.
- Evaluate change controls for regulatory impact and develop appropriate regulatory strategies to support product lifecycle management and regulatory compliance.
- Support regulatory due diligence for new in-licensing opportunities.
- Establish and maintain strong working relationships and communication with all key stakeholders, including regulatory authorities, licensors, Commercial, Medical, Market Access, Quality, Pharmacovigilance and Supply Chain.
- Lead the in-licensing team’s contribution to consultation papers from regulatory authorities and industry bodies.
- Review and update SOPs, guidelines, work instructions and contribute to global system and process improvement projects.




- Support the review of business agreements including licensing agreements, quality agreements and pharmacovigilance agreements.
- Collaborate cross-functionally with Medical, Safety and Commercial teams to develop high-quality PI, CMI, and labelling materials tailored to the Australian and Recent Zealand markets.
- Effectively manage regulatory aspects of medicine shortages to ensure compliance.
- Maintain regulatory databases and records to ensure accuracy, completeness, and compliance with internal SOPs and regulatory requirements.
- Provide regulatory support during inspections and audits, including preparation, document management, and follow-up of corrective actions.

Qualifications And Experience

- A degree in Biological or Medical Science or Pharmacy.
- Proven track record of successful regulatory submissions for prescription medicines in Australia and New Zealand.
- Strategic and tactical thinking ability, complemented by a “hands on” operational approach and strong commercial awareness.
- Ability to identify the impact of regulatory changes to other functions and to communicate changes, regulatory strategy and needs.
- Ability to handle multiple projects and demonstrated ability to meet milestones.
- Highly effective written and verbal communication skills and presentation skills.
- Excellent planning, organising and time management skills.

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📌 Principal Associate, Regulatory Affairs (Melbourne)
🏢 CSL
📍 Melbourne