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Regulatory Affairs Professional

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Sydney, New South Wales, Australia beBeeCompliance Full time $100,000 - $150,000

About Regulatory Affairs.

The Opportunity

As a regulatory affairs associate, you will play a critical role in enabling the registration of life-changing healthcare solutions for patients. Your focus will be on leading submissions and activities that maintain compliance within regulatory strategic partnerships, and mitigating risks.

Key Responsibilities
  • Develop Regulatory Strategies: Implement strategies to ensure products remain registered and labels are optimized throughout the product lifecycle.
  • Collaborate with Stakeholders: Work with cross-functional stakeholders to ensure the entire product portfolio remains compliant with external and internal requirements.
  • Provide Regulatory Input: Offer regulatory expertise into pre-market, post-market, and business activities as required.
Requirements
  • Tertiary Qualification in Life Sciences: Possess a relevant tertiary qualification in a life sciences field.
  • Regulatory Experience: Have 2+ years' experience in a regulatory affairs or compliance role in the pharmaceutical industry.
  • Australian and New Zealand Pharmaceutical Regulations: Understand the Australian and New Zealand Pharmaceutical regulatory environments.
  • System Knowledge: Familiarity with Veeva-based systems and Microsoft Office suite (Word, Excel, PowerPoint).
Personal Qualities

You are a driven individual with a passion for regulatory affairs and compliance. You possess excellent communication and problem-solving skills, with a strong attention-to-detail and ability to work effectively in a team environment.

We Offer

Rewarding growth opportunities, a collaborative culture, and a commitment to your well-being and professional development.