Regulatory Affairs Associate

2 days ago

Sydney, Australia Sandoz 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 managing and maintaining current GMP for existing and new manufacturing sites to support supply continuity, ensure compliance with all corporate and local requirements, partner with relevant stakeholders to assist registering complex and interesting products and to expand an already compelling Sandoz product portfolio.
- This is a great opportunity to use your existing project management skills and/or Regulatory Affairs experience to be part of a business improving access to medicine for more people across the country. As a Regulatory Affairs Associate GMP, your role will be to prepare, submit and maintain GMP clearance renewals, create and maintain processes and services through cross-functional team activity and compliance of processes, services, and products in the Australian and New Zealand market.
- Your responsibilities include, but not limited to:
- Ensures rapid and timely approval for GMP renewals, new submissions and continued approved status for all registered manufacturing sites
- Maintenance of GMP database and related trackers to ensure regulatory history is traceable and regulatory documents are easy to locate
- Coordinates, reviews, and may prepare reports

**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:

- To be successful in this role, you will bring:
- Tertiary education in Pharmacy, Science, Chemistry or related
- 2 years plus experience working in the pharmaceutical industry, ideally in Regulatory Affairs in the Australian market
- Demonstrated project management and stakeholder management skills -the ability to engage with and gain information from a wide variety of sources, in order to achieve your goals
- Excellent verbal and written communication skills; ability to work within a highly matrix driven environment

Why consider Sandoz?
- Our number 1 priority is to pioneer patient access to better healthcare. We are a company of firsts. 1st to develop an oral penicillin antibiotic. 1st to develop and launch biosimilars. 1st to launch an FDA-cleared digital therapeutic. And we never stop asking: how can we continue to pioneer access in an ever-more digital and global world?

**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**
- Yes

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