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Regulatory Affairs and Quality Assurance Manager
2 months ago
Company Overview
Hengandhurst is a global biopharmaceutical leader specializing in providing cutting-edge therapies to patients facing unmet medical needs. Our expertise lies in Rare Diseases, where we introduce groundbreaking treatments worldwide, transforming the lives of individuals battling severe illnesses.
Job Summary
We are actively recruiting for the role of the Regulatory Affairs and Quality Assurance Manager to join our international team and contribute to the growth of our Australian footprint.
Key Responsibilities
- Regulatory Strategy and Planning
- 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.
- Quality Management
- 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.
- Audit and Compliance
- 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.
Requirements
- Education
- Life Science Degree or equivalent
- Experience
- 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
- Preferred Qualifications
- Candidates with experience in Regulatory Affairs and Quality Assurance with rare disease products will be highly regarded.
What We Offer
This is an exciting opportunity to work as part of an international team and contribute significantly to the organization's success. Hengandhurst offers a chance to make a substantial difference and grow its Australian footprint.
