Medical Therapies Coordinator

1 week ago

Sydney, New South Wales, Australia beBeeAdministration Full time $90,000 - $120,000

Medicine Innovation Specialist

In a world where groundbreaking treatments meet cutting-edge innovation, we're seeking talented individuals to fill key roles. Our mission is clear: to serve patients with pioneering therapies and solutions. We're reimagining the way we work, creating more flexibility than ever before.

Your Key Role

We have an exciting opportunity in our Regulatory Affairs team, reporting directly to the Director of Regulatory Affairs. As a specialist in this field, you will provide administrative support to our local team and work closely with internal and external stakeholders. This role offers the perfect blend of administration and regulatory expertise, allowing you to build your career and increase your knowledge of TGA and Medsafe requirements.

Key Responsibilities:

  • Coordinate and execute minor regulatory submissions and general regulatory affairs tasks
  • Prepare, deliver, and electronically archive documentation
  • Implement and coordinate local Regulatory Affairs processes and results
  • Exchange regulatory information and intelligence with colleagues and cross-functional teams as required
  • Support local team members in the development, registration, and lifecycle management of therapeutic molecules
  • Assist in local Compliance activities
  • Participate in local regulatory process improvements, initiatives, and training
  • Coordinate external vendor/contractor relationships

Required Skills and Qualifications

We're seeking a communicative, self-motivated, collaborative, curious, and passionate professional with:

  • Tertiary qualifications in science or life/biomedical science or prior Regulatory Affairs Administration experience in the pharmaceutical industry
  • Understanding of regulatory activities and how they affect other projects and/or processes
  • Experience with electronic document management systems and regulatory information systems/databases (preferred)
  • Experience with SAP and/or other financial transaction and purchasing systems in a multinational environment (preferred)

What We Offer

We're committed to delivering for patients, keeping our staff and their families safe, and helping communities reduce exposure to health risks. As a forward-thinking organization, we believe it's our role to lead the way. To do this, we require all employees to be fully vaccinated (with certain exemptions considered on a case-by-case basis).

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