Healthcare Regulatory Specialist

4 days ago

Sydney, New South Wales, Australia beBeeRegulatory Full time

Transforming healthcare solutions is at the forefront of our mission.

The Position

We are driven by a passion to deliver life-changing medical solutions, ensuring everyone has access to quality healthcare today and for generations to come.

As a Regulatory Affairs Associate, you will play a crucial role in enabling the ongoing registration of innovative healthcare products for patients in Australia and New Zealand. Your focus will be on leading submissions and activities that maintain our Licence to Operate and ensure compliance within the Regulatory Strategic Partners Chapter.

This role supports operational compliance, and you will be responsible for developing and implementing optimised regulatory strategies to ensure products remain registered and labels are optimised throughout their lifecycle.

You will develop expertise in local operational processes and systems associated with product information, artwork, planned and ongoing registration activities. You will collaborate with Regulatory Affairs Partners and other cross-functional stakeholders to ensure the entire product portfolio remains compliant with external and internal requirements.

Your responsibilities will include:

  • Preparing, submitting, and managing the approval process of designated regulatory applications to relevant authorities.

  • Developing and implementing effective regulatory strategies to ensure products remain registered and labels are optimised.

  • Developing knowledge and expertise in local operational processes and systems associated with product information, artwork, planned and ongoing registration activities.

  • Collaborating with stakeholders to ensure the product portfolio remains compliant with external and internal requirements.

  • Providing regulatory input into pre-market, post-market, and business activities as required.

  • Assisting with internal and external audits and supporting records management.

To succeed in this role, you will require:

  • A tertiary qualification in a life sciences field.

  • 2 or more years' previous experience in a regulatory affairs or compliance role in the pharmaceutical, biotechnology, or related industry, preferably within the Australian, New Zealand, or other relevant markets.

  • A foundational understanding of the Australian and New Zealand Pharmaceutical regulatory environments.

  • A strong aptitude and genuine interest in learning, using, and coaching others on complex systems.

  • Advanced knowledge of Microsoft Office suite: Word, Excel, PowerPoint, and Google suite.

  • Knowledge of the potential utility of AI and a continuous learning mindset.

  • Excellent attention-to-detail, interpersonal, communication, analytical, and problem-solving skills.

  • Good organisational and time management skills.

This role requires full eligibility to live and work in Australia.

We strive to create a collaborative culture where people are united in purpose and empowered to make decisions. We encourage a high-performance culture where individuals are trusted and valued.

Our goal is to deliver life-changing healthcare solutions that improve patient outcomes and make a global impact.

We believe it's urgent to deliver medical solutions right now – even as we develop innovations for the future.

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