Regulatory Affairs Consultant

15 hours ago

Melbourne, Victoria, Australia beBeeRegulatoryAffairs Full time $98,918 - $144,113

Job Title: Regulatory Affairs Consultant

About the Role:
  • We are seeking a skilled Regulatory Affairs Specialist to join our team. The successful candidate will play a key role in delivering high-quality regulatory outcomes, optimising submission strategies, and contributing to the continuous improvement of regulatory processes and team capability.
Main Responsibilities:
  1. Prepare and submit regulatory dossiers to relevant authorities, including New Medicine Applications (NMAs), Variations, Notifications, product information updates, and safety-related changes.
  2. Evaluate and implement regulatory frameworks and guidance to ensure compliance.
  3. Serve as the regulatory project coordinator for assigned submissions, tracking deliverables, timelines, and risk mitigation plans.
  4. Liaise cross-functionally with medical, safety, quality, and supply chain teams for compilation of submission-ready documentation.
  5. Handle lifecycle management of prescription medicines, including labelling updates, renewals, and post-approval commitments.
  6. Respond to agency queries and deficiency letters within defined timelines.
  7. Maintain internal regulatory trackers, databases, and submission archives in accordance with SOPs.
  8. Monitor changes in local regulatory guidelines and communicate impact assessments as needed.
Requirements:
  • A bachelor's degree in science, pharmacy or a related discipline.
  • A minimum of 5 years' experience in regulatory affairs, preferably in a commercial environment.
  • Experience in reviewing 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.
Key Skills:
  • Regulatory Affairs
  • Clinical Data Review
  • Project Management
  • Communication
  • Problem-Solving
  • Computer Literacy
  • Confidentiality
Working Conditions:

The ideal candidate will have a strong understanding of regulatory frameworks and guidelines, excellent communication skills, and the ability to work effectively in a team environment.

This is a challenging and rewarding opportunity for an experienced Regulatory Affairs Specialist to take on a key role in shaping the company's regulatory strategy.

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