Regulatory Affairs Specialist
15 hours ago
Hengandhurst is seeking a highly skilled Regulatory Affairs and Quality Assurance Manager to join our team in NSW. As a key member of our organization, you will be responsible for ensuring compliance with regulatory requirements and maintaining the highest standards of quality in our rare diseases biopharmaceutical products.
Key Responsibilities:- Develop and execute strategic submission plans for Marketing Authorisations and NDAs in ANZ, ensuring compliance and launch readiness.
- Liaise with regulatory authorities, 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.
- Life Science Degree or equivalent
- Several years of experience in the Australian Pharmaceutical Industry both in Regulatory Affairs and Quality Assurance
- 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
This is an exciting opportunity to work as part of an international team and grow Hengandhurst's Australian footprint. If you are a motivated and experienced professional looking to make a significant impact, please submit your application in WORD format by clicking 'apply'; or contact Jasmine Garbino on for further queries. Confidentiality is assured.
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