Regulatory Affairs Expert

3 weeks ago

Sydney, New South Wales, Australia Johnson & Johnson Full time

Company Overview

Janssen, a pharmaceutical company dedicated to developing life-changing treatments, is seeking a skilled Senior Regulatory Affairs Associate to join its team. With a focus on product innovation and customer satisfaction, Janssen strives to deliver exceptional outcomes for patients and customers.

Salary: $120,000 - $160,000 per annum, based on experience, plus benefits and bonuses.

About the Role

This 12-month contract position offers an exciting opportunity to lead regulatory strategies and manage local submissions for Australia and New Zealand. As a key member of the Regulatory Affairs team, you will collaborate with global, regional, and local colleagues to ensure high-quality and timely outcomes.

Responsibilities:

  • Liaise proactively with colleagues to manage applications throughout the submission and evaluation processes.
  • Lead cross-functional project teams to develop and execute pipeline strategies for launch excellence.
  • Provide regulatory guidance and expertise to other functions within Janssen.
  • Maintain compliance with local regulation requirements and corporate standards.

Requirements

To succeed in this role, you should possess:

  • A Bachelor's Degree in Pharmacy or Science.
  • Previous experience in Regulatory Affairs, preferably in prescription medicines within Australia and New Zealand.
  • Demonstrated technical expertise working with the TGA and Medsafe.
  • A natural growth mindset, strong communication skills, and excellent stakeholder management abilities.

Benefits

Janssen offers a competitive remuneration package, including:

  • A salary range of $120,000 - $160,000 per annum.
  • Ongoing training and support.
  • Award-winning leadership development programs.

Why Work at Janssen?

Janssen is a Great Place to Work Certified company, recognized for its commitment to employee experience. As part of Johnson & Johnson, you will be part of a global healthcare leader dedicated to making a difference in people's lives.

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