Senior Regulatory Affairs Specialist

2 weeks ago

Melbourne, Victoria, Australia beBeeRegulatoryAffairs Full time $80,000 - $120,000
Regulatory Affairs & Operations Consultant

We seek a seasoned regulatory affairs professional to join our team in managing submissions and ensuring compliance with regulatory frameworks.

  • Key Responsibilities:
  • Prepare, review, and submit high-quality regulatory dossiers to relevant authorities, including new medicine applications and variations.
  • Ensure compliance with local and international regulations, tracking changes in guidelines and communicating impact assessments as needed.
  • Liaise cross-functionally with medical, safety, quality, and supply chain teams for compilation of submission-ready documentation.
  • Manage the lifecycle of prescription medicines, including labelling updates and post-approval commitments.
  • Coordinate responses to agency queries and deficiency letters within defined timelines.
  • Maintain internal regulatory trackers, databases, and submission archives in accordance with standard operating procedures.
Requirements and Qualifications
  • A bachelor's degree in science, pharmacy, or a related field.
  • A minimum of 5 years' experience in regulatory affairs, preferably in a commercial environment.
  • Strong knowledge of legislation, regulations, and working procedures within Australia, New Zealand, and the JAPAC region.
  • Excellent written and oral communication skills, with the ability to deal with confidential information.
  • Proven problem-solving and project management skills, with reasonable computer literacy.

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