Regulatory Affairs Expert

20 hours ago

Melbourne, Victoria, Australia beBeeRegulatory Full time $120,000 - $140,000
Regulatory Affairs Professional Opportunity

This role plays a pivotal part in delivering high-quality regulatory outcomes, optimizing submission strategies, and contributing to the continuous improvement of regulatory processes and team capability.

  • Prepare, review, and submit regulatory dossiers to relevant authorities, including new medicine applications, variations, notifications, product information updates, and safety-related changes.
  • Ensure compliance with regulatory frameworks and guidance.
  • Serve as the regulatory project coordinator for assigned submissions, tracking deliverables, timelines, and risk mitigation plans.
  • Liaise cross-functionally with medical, safety, quality, and supply chain teams for compilation of submission-ready documentation.
  • Handle lifecycle management of prescription medicines, including labelling updates, renewals, and post-approval commitments.
  • Respond to agency queries and deficiency letters within defined timelines.
  • Maintain internal regulatory trackers, databases, and submission archives in accordance with standard operating procedures.
  • Monitor changes in local regulatory guidelines and communicate impact assessments as needed.
Requirements
  • Bachelor's degree in science, pharmacy, or a related discipline.
  • Minimum 5 years' experience in regulatory affairs, preferably in a commercial environment.
  • Experience in reviewing, critically evaluating, and presenting clinical data.
  • Good knowledge of legislation, regulations, guidelines, and working procedures within Australia, New Zealand, and the JAPAC region.
  • High-level written and oral communication skills.
  • Proven problem-solving and project management skills.
  • Reasonable computer literacy.
  • Ability to deal with confidential information.
  • Previous experience in project management and/or consulting.
Why Choose This Role?
  • Collaborate with experts in regulatory affairs.
  • Contribute to projects that have real-world impact on patient care.
  • Enjoy a flexible work model and commitment to work-life balance.
  • Join an organization that values expertise, purpose, and progress.

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