Regulatory Affairs Specialist

1 day ago

Sydney, New South Wales, Australia beBeeRegulatory Full time $115,000 - $125,000
Regulatory Affairs Specialist

This is a rare opportunity to shape the regulatory and quality landscape for a growing organization.

Key Responsibilities:
  • Lead the development and execution of strategic regulatory submission plans and support new registrations.
  • Liaise with regulatory bodies, acting as the primary contact for meetings, submissions, and query management.
  • Collaborate with global regulatory teams to prepare and submit high-quality dossiers and ensure 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.
  • Manage third-party vendors and monitor performance against KPIs.

You will bring extensive experience in Regulatory Affairs within the pharmaceutical industry, an in-depth understanding of regulatory processes, GxP standards, and local regulatory and compliance requirements. You will have proven ability to lead cross-functional projects, manage stakeholders, and influence strategy, excellent communication, problem-solving, and project management skills, and a proactive mindset with strong attention to detail and accountability.

What We Offer:
  • A supportive leadership team, collaborative culture, well-resourced infrastructure, and a flexible working environment.

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