Regulatory Affairs & Quality Assurance Manager | Biologicals | Nsw

Global rare diseases biopharmaceutical company with strong pipeline. Technological and innovative drug discovery. Patient-centred and cooperative team

• International and exciting rare diseases portfolio
• Internal growth development opportunities
• Highly cooperative and diverse culture

This global biopharmaceutical leader specialises in providing cutting-edge therapies to patients facing unmet medical needs. Their expertise lies in Rare Diseases, where they introduce groundbreaking treatments worldwide, transforming the lives of individuals battling severe illnesses. Presently, we are actively recruiting for the role of Regulatory Affairs Manager, who will also be responsible for coordinating Quality Assurance activities.

Reporting to the Operations Manager, your responsibilities will include:

• Develop and execute strategic submission plans for Marketing Authorisations and NDAs in ANZ, ensuring compliance and launch readiness.
• Liaise with TGA, preparing and finalizing regulatory dossiers, and coordinating responses to evaluation questions.
• Manage change control notifications, maintain regulatory files, and provide local expertise for timely review of promotional material.
• Maintain knowledge of SOPs, guidelines, and resolve regulatory issues collaboratively with cross-functional teams.
• Maintain and enhance ANZ Quality Management System in line with global/regional standards, overseeing operational activities and document control processes.
• Establish and maintain Quality Technical Agreements with third-party vendors, ensuring staff compliance with QMS requirements.
• Ensure audit readiness, maintain good documentation practices, and assist in company and Health Authority audits.
• Implement relevant changes from global regulatory intelligence and administer the electronic quality management system for ANZ.

The successful candidate will have:

• Life Science Degree or equivalent
• Several years of experience in the Australian Pharmaceutical Industry in Regulatory Affairs. Experience in Quality Assurance is preferred but not essential. 
• Must have had experience with Cat 1 submissions end-to-end.
• Confidence liaising with senior stakeholders across APAC and global
• Exposure to GMP and QMS preferred
• Experience in working cross-functionally on multiple projects including audits
• Ability to effectively liaise with regulatory authorities
• Proactive problem-solver skills and be a team collaborator

Candidates with experience in Regulatory Affairs experience with oncology or rare disease products will be highly regarded. This is an exciting opportunity to work as part of an international team and grow its Australian footprint! This role offers a chance to make a substantial difference and contribute significantly to the organization's success.

To apply for this role please submit your application in WORD format by clicking 'apply'; or contact Jasmine Garbino on 0460 947 *** for further queries. Confidentiality is assured.