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Global Regulatory Solutions Expert

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Sydney, New South Wales, Australia beBeeRegulatory Full time $150,000 - $200,000
Regulatory Portfolio Specialist

The Regulatory Portfolio Specialist provides strategic support to international regulatory teams.

Key Responsibilities:
  • Support the development of regulatory strategies for local affiliates in tenders, out-of-stock reporting, annual product quality reviews, and risk minimization plans.
  • Act as a liaison between RIO Execution Hub Team Lead and key stakeholders for processes under responsibility.
  • Collaborate with grow submission managers and regional submission hubs to deliver growth applications meeting commercial priorities and operational plans.

The Regulatory Portfolio Specialist is responsible for end-to-end management of multi-regional, regional, and national regulatory dossiers for assigned cluster/country/therapeutic area/products.

This role executes the GRS mission by delivering against goals, executing initiatives, implementing new opportunities, and filling gaps related to the production of regulatory international and operational support.

Success in this role is measured by the timeliness, quality, compliance, and efficient delivery of critical on-the-job deliverables, bringing efficiencies to the organization.

The Regulatory Portfolio Specialist must have a proven technical aptitude and ability to quickly learn and use new software, regulations, and quality standards.

This role acts as a regulatory matter expert with extensive regulatory expertise working across different clusters and/or regions to consolidate Regulatory activity.

Requirements:
  • Bachelor's degree in a relevant field (e.g., pharmacy, life sciences, business, or information technology); equivalent relevant professional experience will be considered.
  • Advanced to fluent English language required; multilingual skills desirable.
  • Familiarity with pharmaceutical organizational structures, systems, and culture.
  • An understanding of country/cluster regulatory requirements and trends is preferred.
  • Relevant experience within pharma, in Regulatory, quality, and/or compliance fields.