Regulatory Affairs Manager

3 months ago

Manly, Australia On Demand HR Full time

About Us

Based in Sydney, Cannim was established in 2017 to bring the benefits of medicinal cannabis to the world. Just 6 years later, Cannim cultivates in Jamaica, Canada and Australia, and established a network of EU GMP manufacturers as well as formed alliances in education and healthcare, offering products & services to bring relief in many forms to people across the world.

About the Role

We are seeking a Regulatory Affairs Manager to lead our team located in Manly, to ensure the management of regulatory applications, monitor and manage licencing and permits. You will be capable of providing regulatory, technical and scientific advice to support regulatory compliance throughout the supply chain.

Your typical duties will include:

Preparing & submitting:

  • Submissions/applications to the TGA Portal for unregistered products, Market Authorisation, exportation of goods, and other regulatory activities for new product launches.
  • Import/export applications and ensure appropriate management of permits and permit limits.
  • Licences: Applications and maintenance to ensure  timely extentions of all relevant licenses and permits.
  • Accurate regulatory reports to the applicable authorities and ensure relevant product databases are maintained.

Compliance, Support & Relationships:

  • Effectively research and interpret current legislation and provide guidance to the Management on legal regulatory obligations.
  • Keep up to date with regulatory requirements for packaging and advertisement and review packaging and advertising materials to monitor compliance.
  • Effectively manage regulatory relationships with the Minister of Health (MOH), Office of Drug Control (ODC), the Therapeutic Goods Administration (TGA) and State and Territories’ Health Departments.
  • Provide regulatory support to overseas affiliates to achieve successful regulatory approval.

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