Regulatory Affairs Coordinator
4 weeks ago
We are seeking a highly motivated and detail-oriented Regulatory Affairs & Pharmacovigilance (RA & PV) Coordinator to join our Clinical, Medical, Regulatory (CMR) Oceania team at Novo Nordisk. As a key member of our team, you will play a crucial role in ensuring regulatory compliance for new products and product amendments, while safeguarding patients by ensuring our medicines are safe to use.
Key Responsibilities- Provide operational and compliance assistance for regulatory submissions and departmental activities, including regulatory systems activities where required.
- Manage the regulatory inbox and payment reconciliation, assist with Good Manufacturing Practice (GMP) clearances to ensure timely renewals, and assist with product permit and licence processes for Australia/New Zealand.
- Ensure timely action on follow-up requests from Novo Nordisk Global Safety regarding reported pregnancies, adverse events, and serious adverse events by collaborating with safety case reporters, healthcare professionals, and business partners.
- Conduct reconciliation and quality control of safety information reports with internal and external partners.
- Assist the development of PV training for internal staff and external partners, contribute to the creation of new PV tools, and assist with PV retention and archiving in accordance with Novo Nordisk requirements.
- Ensure compliance with regulatory requirements, Novo Nordisk global and local regulatory and PV standards, and adherence to Novo Nordisk's quality systems, procedures, and the Novo Nordisk Way.
- Degree level or equivalent in biological/chemical sciences, pharmacy, or a medical sciences discipline.
- A minimum of 6 months experience in RA and PV within the pharmaceutical or healthcare industry.
- Good oral and written English communication skills, along with basic computer literacy and IT skills.
- Must either be an Australian Citizen or Permanent Resident.
We are a proud life-science company, and life is our reason to exist. We're inspired by life in all its forms and shapes, ups and downs, opportunities, and challenges. For employees at Novo Nordisk, life means many things – from the building blocks of life that form the basis of ground-breaking scientific research, to our rich personal lives that motivate and energize us to perform our best at work. Ultimately, life is why we're all here - to ensure that people can lead a life independent of chronic disease.
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