Regulatory Affairs Associate

7 hours ago

New South Wales NSW Sandoz, Australia Sandoz Full time $80,000 - $120,000 per year

Job Description Summary

We're looking for a proactive and detail-oriented Regulatory Affairs Associate to join our team at Sandoz Australia on a full-time basis. This role is critical to ensuring timely registration and maintenance of our pharmaceutical products across the Australia and New Zealand markets. You'll work closely with internal and external stakeholders to support product lifecycle management, compliance, and successful market access.

Job Description

As part of the Regulatory Affairs team, you will contribute to high-impact outcomes by:

  • Preparing, submitting, and maintaining registration applications to the Therapeutic Goods Administration (TGA) and Medsafe (New Zealand) within agreed timeframes.

  • Reviewing regulatory dossiers to identify and mitigate gaps, reducing regulatory risk and implementing strategies to overcome deficiencies.

  • Liaising with international parent and license companies to acquire documentation, product samples, and responses to health authority queries.

  • Managing regulatory activities related to maintaining registered product details and updating Product Information and Consumer Medicine Information documents.

  • Communicating application progress and outcomes to internal stakeholders, ensuring regulatory histories are traceable and documentation is accessible.

  • Updating regulatory databases such as Change Management and Regulatory Information Management systems.

  • Preparing and submitting artwork for approval, ensuring regulatory compliance of site proofs.

  • Staying current with Australian, New Zealand, and international regulatory requirements and assessing their impact on the Sandoz pipeline and product portfolio.

What You'll Bring to the Role

  • Experience in regulatory affairs, ideally within the pharmaceutical industry

  • Knowledge of TGA and Medsafe requirements

  • Strong attention to detail and accuracy

  • Clear and confident communication skills

  • Ability to manage multiple tasks and meet deadlines

  • A collaborative, team-focused mindset

  • Proficiency with regulatory systems and documentation tools

  • Willingness to learn and adapt in a fast-paced environment

Why Sandoz?

At Sandoz, we're committed to building an inclusive workplace that reflects the diverse communities we serve. We believe that diversity drives innovation and excellence.

Why Sandoz? Over 500 million patients worldwide use our generic and biosimilar medicines, and while we're proud of this, we know there is more we could do to continue to help pioneer access to medicines for people around the world. How will we do this? A diverse, equitable and inclusive environment inspires new ways of working.

The future is ours to shape. Becoming a newly listed organization in 2023 was a once-in-a-career opportunity to define our own path as a purpose-driven Sandoz. This is a moment of immense possibility for all of us, both professionally and personally.

Together we are building the future of Sandoz from the ground up. We are creating an environment that moves quickly, encourages ambition, and offers meaningful careers with flexibility. Our culture is supportive and collaborative, where diversity is embraced and personal and professional growth is actively encouraged.

Imagine what you could do here at Sandoz.

 #Sandoz

Skills Desired

Clinical Study Reports, Data Analysis, Documentation Management, Lifesciences, Operational Excellence, Regulatory Compliance

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