Quality & Regulatory Affairs Associate

2 days ago

Sydney, New South Wales, Australia Buscojobs Full time

Benefits
Ownership of both QA and RA activities with strong mentoring and support
Great opportunity for professional growth and cross-functional collaboration
Work with a global pharmaceutical company committed to continuous improvement
Hybrid working
About the company
This global pharmaceutical company offers a broad range of products across international markets.
It is known for its focus on quality, compliance, and innovation, with teams working together to maintain high standards in manufacturing and regulatory processes.
About the opportunity
This is a fantastic opportunity for an experienced Quality professional with some regulatory exposure to step into a broad, hands-on role.
You'll be responsible for managing key quality systems including change controls, deviations, and complaints, while also supporting regulatory activities across a varied product portfolio.
Working closely with cross-functional teams and external partners, you'll play a central role in maintaining compliance and ensuring timely approvals and documentation.
The position is well-suited to someone looking to take ownership, make process improvements, and contribute to a high-performing and collaborative team.
With hybrid flexibility and strong mentoring, this is a role where you can grow and thrive.
Duties
Act as the liaison between customers and corporate quality functions
Manage change controls, deviations, complaints, and CAPAs
Support product quality reviews and GMP compliance activities
Prepare and submit regulatory variations and notifications to authorities
Provide guidance on labelling and regulatory documentation for submissions
Assist with packaging and artwork issue resolution
Coordinate cross-functional collaboration with R&D, Supply, and Business Development
Identify and support quality system improvements and handle technical queries
Skills and Experience
Tertiary qualification in Science, Pharmacy, or related discipline
3-4 years of experience in pharmaceutical Quality Assurance or Regulatory Affairs
Strong understanding of GMP, TGA, and Medsafe regulatory frameworks
Exceptional attention to detail and organisational skills
Strong stakeholder communication and project coordination abilities
Self-motivated, adaptable, and proactive in driving process improvement
Culture
Join a collaborative and forward-thinking team that values open communication, innovation, and continuous learning.
The company encourages initiative and supports career development through exposure to diverse projects and global best practices.
How to Apply
Ready to take the next step?
Click apply or contact Gemma Staddon on gstaddon@hpgconnect 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
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