Regulatory Affairs Associate Compliance

2 weeks ago

Sydney, New South Wales, Australia Novartis Full time

5 million. This is the number of products that Sandoz, a part of the Novartis Group of Companies, distributes into the Australian & New Zealand market every single month. Join the Team of the Year at Sandoz ANZ where you can actively contribute to this number by assisting the regulatory feasibility assessments, formulating submission strategies and registering complex and interesting products to expand an already compelling Sandoz portfolio.
This is a great opportunity to use your pharmacy or pharmaceutical industry experience to be part of a business improving access to medicine for more people across the country in this entry-level role. As a Regulatory Affairs Compliance Associate, your role is to provide effective operational and regulatory support for assigned regulatory submission and maintenance activities, including preparation and submission of regulatory dossiers, maintenance of regulatory databases and archives and artwork-related activities.
Your responsibilities include, but not limited to:

- Directs the development of submission of product registration, progress reports, supplements, amendments, and/or periodic experience reports.
- Ensures compliance with innovator product information as per conditions of registration. Manages and documents change along with dissemination of information to external stakeholders and publication of updates on health authority websites.
- Engages with patient safety and QA as required. Manages tracking and reporting of all regulatory commitments. Ensures rapid and timely approval on of new drugs, biologics/biotechnology and/or medical devices and continued approved status of marketed drugs or medical devices.
- Provides advice to development and/or marketing teams on manufacturing changes, line extensions, technical labelling, appropriate regulations and interpretations.
- Coordinates, reviews, and may prepare reports for submission.

**Commitment to Diversity & Inclusion**:

- Novartis is committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve._

**Minimum requirements**

What you'll bring to the role:

- Tertiary education in Pharmacy, Science, or Chemistry
- 1-2 years' experience working in the pharmaceutical industry, ideally in Regulatory Affairs in the Australian market or alternatively a background in Hospital or Community Pharmacy
- Ability to work in a sometimes ambiguous, fast-paced matrix environment
- Strong collaboration skills and desire to work towards common goals in a team
- Excellent verbal and written communication skills

**Division**

SANDOZ

**Business Unit**

Commercial OPS SIR SZ

**Country**

Australia

**Work Location**

Sydney

**Company/Legal Entity**

AU Sandoz Pty ltd

**Functional Area**

Research & Development

**Job Type**

Full Time

**Employment Type**

Regular

**Shift Work**

No

**Early Talent**

No

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