Regulatory Affairs & Quality Associate

Benefits

• Permanent opportunity within an international pharmaceutical company
• Broad role across both Regulatory Affairs and Quality Assurance
• Work closely with local, regional and global stakeholders

About the company A global pharmaceutical organisation with an established Australian presence and a strong commitment to quality, compliance and patient outcomes.

About the opportunity An exciting opportunity has become available for a Regulatory Affairs & Quality Associate to join a growing pharmaceutical organisation. This is a broad, hands-on role spanning both QA and RA activities. You will support the ongoing management of the QMS while also gaining exposure to regulatory submissions, product lifecycle activities, artwork and labelling, TGA requirements and GMP clearances.

Duties

• Support day-to-day Quality Management System activities including deviations, CAPAs, change controls, complaints and quality documentation
• Assist with document control, SOPs, training records and continuous improvement activities
• Support TGA GMP clearances, including applications, renewals, supporting documentation and tracking
• Assist with supplier qualification, vendor compliance and quality agreements
• Support batch release, product quality reviews, complaints, recalls and quality investigations
• Maintain regulatory dossiers, submission records and product-specific regulatory documentation
• Support ARTG applications and preparation of regulatory submission documentation
• Review product labels, artwork and packaging for regulatory compliance
• Support product lifecycle activities including registrations, variations, renewals and regulatory approvals

Skills and Experience

• Tertiary qualification in Pharmacy, Pharmaceutical Sciences, Life Sciences, Biotechnology, Chemistry, Microbiology or a related discipline
• Experience within pharmaceutical Quality Assurance, Regulatory Affairs or a related environment
• Understanding of GMP requirements and pharmaceutical quality systems
• Exposure to QMS processes such as deviations, CAPAs, change controls or complaints would be highly regarded
• Knowledge or exposure to TGA regulatory requirements would be advantageous
• Experience within a pharmaceutical sponsor, manufacturer or distribution environment would be beneficial
• Strong attention to detail and documentation skills
• Excellent organisation and time management skills with the ability to manage competing priorities
• Strong communication and stakeholder management skills
• Ability to work independently while contributing effectively within a cross-functional team

Culture Join a collaborative and quality-focused environment where you will work across multiple areas of the business and have the opportunity to broaden your Regulatory Affairs and Quality Assurance experience.

How to Apply Ready to take the next step? Click apply or contact Gemma Staddon on [email protected] for a confidential discussion.

About Healthcare Professionals Group Healthcare Professionals Group recruits all positions: executive, permanent, contracting/temp, at all levels, across all areas of healthcare - Pharmaceuticals, Biotechnology, Medical Technology and Clinical Care.

• Medical Affairs & Life Sciences Recruitment - Clinical Research, Market Access, Medical Affairs, Pharmacovigilance, Quality, Data Management, Regulatory Affairs, Scientific;
• Commercial Recruitment - Marketing, Sales, Analytics, Government and External Affairs;
• Business Operations & Infrastructure Recruitment - Administration, Customer Service, Engineering, Finance, Human Resources, IT, L&D, Legal, Manufacturing, Operations, Supply Chain, Warehouse;
• Clinical Care Recruitment - Allied Health, Aged Care, General Practice, Medical Imaging, Medical Management, Medical Specialties, Nursing.