Senior Regulatory Affairs Associate

Healthcare Professionals Group

  • Melbourne, VIC
  • $54.00-55.00 per hour
  • Permanent
  • Full-time
  • 11 days ago
About the company Join a globally recognised biopharmaceutical leader with an outstanding portfolio of life-changing products. This organisation is known for its culture of collaboration, regulatory excellence, and commitment to patient outcomes. With a strong APAC presence and a trusted brand, you'll enjoy stability and flexibilityAbout the opportunity Due to internal growth and product expansion, an opportunity has become available for an experienced Senior Regulatory Affairs associate to support the APAC regulatory function. This role focuses on established products and offers a unique mix of submission responsibility, strategic contribution, and cross-functional collaboration.Duties
  • Prepare and manage submissions: new licenses, renewals, variations, PSURs, DSURs, and post-approval changes.
  • Lead preparation of documentation for health authority meetings on mature products.
  • Liaise with Global Regulatory Leads, providing local and regional input
  • Submit all regulatory documentation to Health Authorities in a timely, compliant manner.
  • Respond to health authority queries and manage preparation of answers to both basic and complex regulatory questions.
  • Independently file CAT 1 and CAT 3 applications under TGA requirements.
Skills and experience
  • Degree in Biological or Medical Science, Pharmacy, or a related field. Postgraduate studies in Regulatory Affairs are a strong advantage.
  • Minimum 3+ years' experience in a regulatory affairs role with a focus on pharmaceuticals.
  • Minimum 3 years experience in CAT 1/CAT 3
  • Strong knowledge of TGA requirements and regulatory frameworks.
  • Understanding of GMP, GCP, and GLP.
  • Confident communicator who can collaborate across teams and influence decision-making.
  • Strategic and solution-oriented mindset with excellent attention to detail.
Culture This organisation fosters a supportive, high-performance culture. You'll work in a collaborative and diverse team environment where initiative is recognised and regulatory professionals are seen as strategic business partners.Benefits
  • Global company with long-term career development opportunities.
  • Hybrid working model - work-life balance encouraged.
  • Be part of an organisation with purpose and social impact.
  • Excellent internal training and support infrastructure.
How to apply
Click APPLY or contact Jo Turner, Divisional Manager on +61488807377 for a confidential discussion.About HPG
Healthcare Professionals Group (HPG) is Australia's leading recruitment partner to the healthcare and life sciences industries. With 28+ years of success and specialist divisions across pharmaceuticals, biotechnology, and scientific recruitment, we deliver a personalised, high-integrity experience for both candidates and clients.Visit www.hpgconnect.com to explore more roles in regulatory affairs and life sciences.

Healthcare Professionals Group