Regulatory Operations Specialist

3 days ago

Sydney, New South Wales, Australia beBeeRegulatory Full time $110,000 - $146,000

Overview of Role:

The RIO Execution Hub Manager plays a pivotal role in delivering high-quality regulatory support to international teams.

Main Responsibilities:
  • Manage end-to-end regulatory processes for assigned projects, including initial submissions and ongoing lifecycle management through to product withdrawal.
  • Collaborate with Regulatory Strategists and Submission Managers to ensure timely, compliant submissions.
  • Identify regulatory requirements, author, deliver, and/or coordinate local submission-ready documents, and quality review/approve Dossiers provided by Submission Managers.

Experience and Skills:

  • Provides regulatory support for complex activities in the assigned region.
  • Leads regulatory support to teams with challenging internal and external constraints.

Requirements:

  • Bachelor's degree in relevant field (e.g. Pharmacy, Life Sciences, Business, IT).
  • Advanced fluency in English required, multilingual skills beneficial.

Key Qualifications:

  • Regulatory expertise with ability to interpret and apply complex regulations.
  • Strong analytical and problem-solving skills, with attention to detail.

We Offer:

  • A dynamic work environment with opportunities for growth and development.

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