Regulatory Affairs

Regulatory Affairs & PV Coordinator (Contract)

**Category**:Reg Affairs & Safety Pharmacovigilance**Location**:Sydney, New South Wales, AU**About the department**
You will be part of the Clinical, Medical, Regulatory (CMR) Oceania (Australia and New Zealand) team, reporting directly to the Senior RA Manager. Our team is focused on ensuring regulatory compliance for new products and product amendments, thereby keeping our license to operate. We work closely with health authorities and policymakers to shape future regulatory frameworks. Our Safety PV function safeguards patients by ensuring our medicines are safe to use, collecting and analysing safety data, and addressing any product safety issues that arise. Located in our dynamic and collabo-rative office, you will be part of a team that is devoted to making a difference in the lives of patients.**The position**
As RA & PV Coordinator, you will support Novo Nordisk Oceania in fulfilling the Novo Nordisk global requirements and local regulatory requirements.- 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 re-ported 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.

**Qualifications**
- 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.

**Working at Novo Nordisk**
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.

**Contact**Deadline**
- We commit to an inclusive recruitment process and equality of opportunity for all our job applicants.- At Novo Nordisk we recognize that it is no longer good enough to aspire to be the best company in the world. We need to aspire to be the best company for the world and we know that this is only possible with talented employees with diverse perspectives, backgrounds and cultures. We are therefore committed to creating an inclusive culture that celebrates the diversity of our employees, the patients we serve and communities we operate in. Together, we’re life changing.- #LI-AMS1