Regulatory Affairs Specialist
7 days ago
About Us
Cannim is a leading medicinal cannabis company established in 2017 to bring benefits to the world. With a presence in Jamaica, Canada, and Australia, and a network of EU GMP manufacturers, we offer products and services to bring relief to people globally.
About the Role
We are seeking a Regulatory Affairs Manager to lead our team in Manly, ensuring the management of regulatory applications, monitoring and managing licenses and permits. This role requires providing regulatory, technical, and scientific advice to support regulatory compliance throughout the supply chain.
Your key responsibilities will include:
Preparing and Submitting:
- Submitting applications to the TGA Portal for unregistered products, Market Authorisation, exportation of goods, and other regulatory activities for new product launches.
- Managing import/export applications and ensuring appropriate management of permits and permit limits.
- Maintaining licenses: Applications and maintenance to ensure timely extensions of all relevant licenses and permits.
- Providing accurate regulatory reports to the applicable authorities and ensuring relevant product databases are maintained.
Compliance, Support, and Relationships:
- Effectively researching and interpreting current legislation and providing guidance to management on legal regulatory obligations.
- Staying up-to-date with regulatory requirements for packaging and advertisement and reviewing packaging and advertising materials to monitor compliance.
- Effectively managing regulatory relationships with the Minister of Health (MOH), Office of Drug Control (ODC), the Therapeutic Goods Administration (TGA), and State and Territories' Health Departments.
- Providing regulatory support to overseas affiliates to achieve successful regulatory approval.
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