Senior Regulatory Affairs Associate

17 hours ago

Sydney, New South Wales, Australia Heng & Hurst Full time $80,000 - $120,000 per year

We are excited to be partnering with one of the fastest-growing businesses in Australia, which is currently seeking an experienced Senior Regulatory Affairs Associate to join their team. With a rich pipeline and a steady flow of products, this role is perfect for someone who wants to avoid monotonous work.

This position offers the opportunity to contribute to the delivery of high-quality, affordable medicines and healthcare products that improve health outcomes. You'll work within an experienced and diverse team on innovative products and projects.

The Regulatory Affairs team plays a key role in providing technical and scientific advice, support, and guidance in developing effective regulatory strategies. This role involves preparing and reviewing regulatory submissions, maintaining compliance documentation, and supporting product launches in collaboration with cross-functional teams.

Key Responsibilities

  • Prepare and review regulatory submissions to the TGA and Medsafe to ensure timely approvals. (Cat 1 is a "must have" requirement)
  • Manage variations, renewals, and life-cycle maintenance of registered products.
  • Develop and maintain Product Information, Consumer Medicine Information, labels, and related documentation.
  • Coordinate responses to agency queries and maintain accurate records in internal and external databases.
  • Collaborate with Quality, Supply Chain, Pharmacovigilance, and Marketing teams to support product changes and launches.
  • Stay up to date with regulatory legislation and provide guidance on best practices.
  • Mentor junior team members and support their development within the function.

Candidate Requirements

  • 4+ years' experience in Regulatory Affairs within the pharmaceutical industry.
  • Strong knowledge of TGA and Medsafe guidelines and registration processes.
  • Experience managing Category 1 submissions.
  • Excellent communication, stakeholder management, and problem-solving skills.
  • Ability to work independently and collaboratively in a fast-paced environment.

This is an opportunity to work in a supportive and collaborative environment, contribute to important regulatory outcomes, and grow within a company committed to improving healthcare access and quality.

Applications should be submitted in
WORD format
, or contact
Jasmine Garbino on
for a confidential discussion.

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