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 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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