Regulatory Affairs Specialist

1 month ago

Manly Vale, Australia On Demand HR Full time

About Us

Cannim is a leading company in the medicinal cannabis industry, with a presence in Sydney, Jamaica, Canada, and Australia. We have established a network of EU GMP manufacturers and formed alliances in education and healthcare. Our mission is to bring relief to people across the world through our products and services.

About the Role

We are seeking a Regulatory Affairs Manager to lead our team in Manly. The successful candidate will be responsible for managing regulatory applications, monitoring and managing licenses and permits. They will provide regulatory, technical, and scientific advice to support regulatory compliance throughout the supply chain.

Key Responsibilities

* Prepare and submit submissions/applications to the TGA Portal for unregistered products, Market Authorisation, exportation of goods, and other regulatory activities for new product launches.
* Manage import/export applications and ensure appropriate management of permits and permit limits.
* Maintain licenses: Applications and maintenance to ensure timely extensions of all relevant licenses and permits.
* Provide 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.
* 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.

Requirements

* Strong knowledge of regulatory requirements and compliance.
* Excellent communication and interpersonal skills.
* Ability to work in a fast-paced environment and meet deadlines.
* Strong analytical and problem-solving skills.

If you are a motivated and experienced Regulatory Affairs professional looking for a new challenge, please submit your application.

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