Senior Regulatory Affairs Consultant

1 week ago

Sydney, New South Wales, Australia Healthcare Professionals Group Full time

Benefits

  • A role for an experienced Regulatory Affairs professional.
  • Opportunity for career development and progression within the team.
  • Part time option available and competitive salary package on offer.

About the company

Our client is a leading regulatory consultancy - they are renowned locally and have a strong presence in the national market.

Their expertise lies in providing regulatory support to various pharmaceutical Industry leaders.

About the opportunity

This is a great role for someone with a background in the pharmaceutical industry to take on a challenging and rewarding role in a fast-paced environment.

As a Senior Regulatory Affairs Associate, you will play a crucial role in maintenance activities of prescription products, ensuring compliance with relevant regulations.

In this role you will submit timely applications and respond to regulatory agency requests for information.

To be successful in this role, you will need to be results-oriented, self-motivated, and able to work autonomously.

You will also need to have a good understanding of the TGA submission process and be able to provide accurate and timely regulatory advice.

This is an exciting opportunity to join a close-knit team of professionals who work together manage the lifecycle of products.

This role also has the option of being part time (4 days per week).

Duties

  • Ensuring timely submission and responding effectively and efficiently to Agency RFIs to achieve a favourable outcome.
  • Provide accurate and timely regulatory advice to the business teams.
  • Review and approve advertising materials in compliance with regulations.
  • Assess and provide regulatory assessment to Change Control Requests in a timely manner.
  • Proactively provide accurate and timely regulatory support and advice to local business teams.
**Please note, the ideal candidate has unrestricted working rights in Australia

Skills and Experience

  • Tertiary qualifications in a pharmacy or a life science discipline.
  • 3+ years of experience working in the Australian pharmaceutical industry with prescription products in a regulatory affairs role.
  • Knowledge of Australian Pharmaceutical regulatory requirements and processes, especially CMC.
  • Good understanding of the advertising code of practices and some experiences in reviewing promotional materials.
  • Effective written and verbal communications.
  • Self-motivated & results orientated.

Culture
An incredibly supportive and harmonious team culture that fosters collaboration.

How to Apply
Click apply or contact Gemma Staddon, Specialist Manager, on or Erin Cox, Sourcing Consultant on for a confidential discussion.
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