Regulatory & Pharmacovigilance Associate

Category:  Regulatory
Location: 

Baulkham Hills, NSW, AU

   

  • Australian RA and/or PV experience with prescription medicines required
  • High variety across multiple therapeutic areas
  • Within walking distance of the new Sydney Metro Northwest train link
  • Contract role to December 2020

 

This exciting opportunity would suit a regulatory affairs-focused individual with previous experience in a similar position within the pharmaceutical industry.

 

About the department

Novo Nordisk Oceania, with its head office in Sydney, is a growing and dynamic organisation with passionate and committed employees across Australia and New Zealand.  Our primary therapy area is diabetes where we have a broad range of market-leading products. We furthermore offer a broad range of treatments within the areas of obesity, haemophilia, growth disorders and women’s health.

 

The position

Located at our Sydney head office in Norwest Business Park, and reporting to the Regulatory and Pharmacovigilance Manager, the key responsibilities of the role will be to register and maintain the registrations of biotechnology-based prescription medicines and medical devices, and to ensure compliance with the company's pharmacovigilance system, across Australia and New Zealand.

 

Other key responsibilities include (but are not limited to):

 

  • Preparing and project managing applications for registration and regulatory lifecycle management of medicines and devices;
  • Developing Product Information and Consumer Medicine Information documents;
  • Import permit and Good Manufacturing Practice clearance administration;
  • Safety reporting to external and internal authorities;
  • Developing and maintaining relationships with key regulatory authority officers/personnel;
  • Attending appropriate industry conferences and meetings.

 

Qualifications

The successful applicant will have associate-level experience with Australian registration and/or pharmacovigilance systems for prescription medicines.  Experience with both functions would be advantageous, as would a professional background working with innovative biological medicines.

 

You will have a tertiary degree in a biological, chemical or medical science, high attention to detail, strong oral and written communication skills, as well as being adaptable, keen to learn, and willing to juggle many balls at any one time.

 

You must either be an Australian Citizen or have a current residency Visa to live and work in Australia.

 

Application Deadline

7 November 2019

 

Millions rely on us
To work for Novo Nordisk you will need the skills, dedication and ambition to change lives for the better for millions of patients living with diabetes and other chronic diseases. In exchange, we offer the chance to be part of a truly global workplace, where passion and engagement are met with opportunities for professional and personal development.