Compliance Expert

5 days ago

Melbourne, Victoria, Australia beBeeRegulatoryAffairs Full time $53,280 - $62,400
Job Summary

We are seeking a highly skilled Regulatory Affairs Specialist to join our team. As a key member of our organization, you will play a crucial role in ensuring compliance with local Health Authority guidelines.

  • Provide expert review of product labels to ensure adherence to HA guidelines and advise on optimal compliance strategies.
  • Conduct Chemistry, Manufacturing, and Controls (CMC) reviews, including CTD Modules, Medical Data Packages, SmPCs, PIs, PILs, and labeling documents, to ensure readiness for HA submissions.
  • Participate in Pre-Submission meetings with the HA and prepare post-meeting documentation and minutes for internal records.
  • Assist in preparing and submitting high-quality dossiers to the HA, including conducting adequacy reviews and gap analyses of technical documentation for the CTD dossier.

You will work closely with internal teams and clients to address comments, review additional data, and ensure successful submission outcomes. Additionally, you will be responsible for maintaining accurate and compliant record-keeping practices, adhering to SOPs, while ensuring data security and compliance.

Key Responsibilities:

  • Post Graduation (Masters in) Pharmacy (M. Pharm) or life Sciences (any related field)

About This Opportunity

This is an excellent chance for a detail-oriented and organized individual who is passionate about regulatory affairs and compliance. If you are looking for a challenging and rewarding role that will allow you to make a meaningful contribution to our team, we encourage you to apply.

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