Regulatory Affairs Specialist

1 day ago

Melbourne, Victoria, Australia beBeeRegulatory Full time $90,000 - $120,000
Regulatory Affairs & Operations Consultant

We are seeking a highly skilled Regulatory Affairs & Operations Consultant to join our team. As a key member of our organization, you will play a crucial role in ensuring compliance with regulatory frameworks and guidelines.

About the Role:
  • You will be responsible for preparing, reviewing, and submitting regulatory dossiers to Medsafe and TGA, including New Medicine Applications (NMAs), Variations (Category 1), Notifications, product information updates, and safety-related changes.
  • You will ensure that all submissions meet the required standards and deadlines, and maintain accurate records of submission progress.
  • You will serve as the regulatory project coordinator for assigned submissions, tracking deliverables, timelines, and risk mitigation plans.
  • You will liaise cross-functionally with medical, safety, quality, and supply chain teams for compilation of submission-ready documentation.
  • You will handle lifecycle management of prescription medicines, including labelling updates, renewals, and post-approval commitments.
  • You will respond to agency queries and deficiency letters within defined timelines.
  • You will maintain internal regulatory trackers, databases, and submission archives in accordance with SOPs.
  • You will monitor changes in local regulatory guidelines and communicate impact assessments as needed.
Requirements:
  • A bachelor's degree in science, pharmacy, or a related discipline is essential.
  • A minimum of 5 years' experience in regulatory affairs, preferably in a commercial environment, is required.
  • You should have experience in the review, critical evaluation, and presentation of clinical data.
  • You should have good knowledge of legislation, regulations, guidelines, and working procedures within Australia, New Zealand, and the JAPAC region.
  • You should possess high-level written and oral communication skills.
  • You should have proven problem-solving and project management skills.
  • You should have reasonable computer literacy.
  • You should be able to deal with a high level of confidentiality.
  • Previous experience in project management and/or consulting is an advantage.
What We Offer:
  • A competitive salary package.
  • Ongoing training and professional development opportunities.
  • A dynamic and supportive work environment.
  • The opportunity to work with a talented team of professionals.

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