Regulatory Affairs Expert

1 day ago

Sydney, New South Wales, Australia beBeeregulatory Full time $115,000 - $125,000
Regulatory Affairs Expert | Rare Disease Specialist

The role of Regulatory Affairs Expert is pivotal in the development, approval, and lifecycle management of innovative medicines. This global position offers a unique opportunity to take full ownership of regulatory affairs across ANZ.

  • Develop and execute strategic regulatory submission plans to support new registrations.
  • Liaise with TGA and Medsafe, acting as the primary contact for meetings, submissions, and query management.
  • Collaborate with global regulatory teams to prepare and submit high-quality dossiers, ensuring launch readiness.
  • Maintain regulatory documentation and GMP clearance in alignment with SOPs and local requirements.
  • Provide regulatory input into business development, cross-functional projects, and product lifecycle changes.
  • Oversee QA operations, maintain accurate quality records, manage training programs, and ensure documentation compliance.

This is a rare opportunity to shape the regulatory and quality landscape for a growing affiliate. You will be trusted to work independently, make meaningful decisions, and play a key role in bringing innovative treatments to patients in need.

Key Responsibilities
  • Strategic Planning:
    • Develop comprehensive regulatory strategies to drive successful product launches.
    • Collaborate with cross-functional teams to align regulatory objectives with business goals.
  • Regulatory Compliance:
    • Maintain up-to-date knowledge of local regulations, guidelines, and standards.
    • Evaluate and implement process improvements to enhance regulatory compliance.
  • Communication:
    • Foster strong relationships with internal stakeholders, including R&D, Manufacturing, and Commercial teams.
    • Effectively communicate complex regulatory information to diverse audiences.

You will bring extensive experience in Regulatory Affairs within the Australian pharmaceutical industry. In-depth understanding of TGA and Medsafe processes, GxP standards, and local regulatory and compliance requirements are essential. Proven ability to lead cross-functional projects, manage stakeholders, and influence regional strategy is also required.

Benefits
  • Flexible Working Environment
  • Dynamic Leadership Team
  • Collaborative Culture
  • Well-resourced Global Infrastructure

This position offers a unique blend of challenge and opportunity. If you are a motivated professional with a passion for regulatory affairs, this could be the ideal role for you.

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