Regulatory Affairs Assistant

6 days ago

Sydney, New South Wales, Australia Novo Nordisk Full time

**About the Department**

The Regulatory Affairs group is accountable in ensuring that Novo Nordisk Oceania' business operation is fully compliant with legislation and regulations. As a Regulatory Affairs (RA) Assistant, you will be part of a highly engaged Oceania Regulatory Affairs team based in a brand-new modern office in North Sydney.

**The Position**

In this role, you will be working in a cross functional setup providing top-quality administrative and technical assistance to the RA team members and other Novo Nordisk stakeholders enabling them to achieve business targets efficiently and effectively.

Duties include, but not limited to:

- Assisting compliance activities such as uploading product information and consumer medicine information documents to Therapeutic Goods Authority (TGA) / Medsafe websites and to other internal and external databases and website
- Assisting RA with Good Manufacturing Practice (GMP) paperwork, reviewing and updating the GMP tracker, managing internal regulatory database/system (Q-case), compiling documents, and tracking incoming TGA queries
- Coordinating meetings for regulatory activities, tracking RA budget, checking artwork and proofreading via TVT (adobe proofreading tool) reports

**Qualifications**
- You hold a Technical and Further Education (TAFE)-level diploma in office administration or equivalent
- You have proven experience working in a fast-paced environment as an Administrative Assistant (healthcare industry experience preferred)
- You have excellent data management skills
- You 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 energise 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.

We offer a competitive compensation package, parking and a great working environment.

**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.

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