Senior Life Cycle Management Specialist

4 days ago

Sydney, New South Wales, Australia beBeeRegulatory Full time $90,123 - $123,456

Job Description:

The Regulatory Affairs Associate plays a crucial role in ensuring continuity of supply through lifecycle management activities for existing products and supporting the registration of new medicines in Australia.

Key Responsibilities:

  • Deliver Regulatory Submissions: Timely submission of regulatory documents to ensure compliance with local and global regulations.
  • Maintain Compliance: Ensure accuracy and currency of company databases, systems, and change control records.
  • Provide Regulatory Advice: Offer guidance to personnel on relevant regulations and codes.
  • Cross-Functional Collaboration: Work with teams to support submissions and projects.
  • Administrative Support: Assist with regulatory administrative tasks as needed.

Requirements:

  • Bachelor's degree in Pharmacy, Science, or Chemistry.
  • At least two years' experience in regulatory affairs, preferably with prescription medicines.
  • Understanding of local and international regulatory guidelines.
  • Excellent communication skills (written and verbal).
  • Ability to multitask and work to deadlines.

What We Offer:

  • Competitive salary package.
  • Inclusive environment where you can make an impact.
  • Opportunity to work with a global healthcare leader.

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