Australia: Regulatory Affairs Manager

Regulatory Affairs Manager

On Demand HR
Manly, Sydney NSW
Pharmaceuticals & Medical Devices (Healthcare & Medical)
Full time
$110,000 – $120,000 + Super
Posted 3d ago

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.

Requirements

The successful candidate will have:

  • Previous experience in a Regulatory Affairs role.
  • Previous experience in management of a team
  • A passion about making a difference in people’s lives by bringing them alternative, more holistic medications.

Candidates who have the below characteristics will be highly regarded:

  • A bachelor degree in Pharmacy, Medical Science, Law, Life Sciences (Chemistry or Biology) and/or similar.
  • Regulatory compliance experience in pharmaceutical, complementary medicines, vitamins, cosmetics or other similar industries
  • Experience with TGA and/or other federal / state authorities.

The successful candidate will be required to complete a Police Check.

Benefits

  • Potential for growth – great opportunity for an ambitious candidate!
  • Join a fast-growing, established & stable company
  • Competitive salary offering
  • Strong workplace culture
  • Unique and progressive sector of the Pharmaceutical industry
  • International regulatory affairs experience available

 

Contact Details

If you are a highly motivated individual looking to take the next step in your career, then we would love to hear from you! Please submit your application via the “apply now” or email any questions to [email protected]

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