Regulatory Operations Manager

3 days ago

Sydney, New South Wales, Australia beBeeManager Full time $145,000

The role of a Regulatory Operations Manager involves providing regulatory support to various activities across different clusters and regions. This includes initial applications, commercial lifecycle through to product withdrawal, tenders, audits, and launch planning.

Key Responsibilities
  • Lead regulatory support to countries/clusters with challenging internal and external constraints.
  • Act as a regulatory matter expert working across different clusters and/or regions to consolidate Regulatory activity.
  • Collaborate with strategists and other local and above country cross-functional stakeholders.
Requirements
  • Bachelor's degree in Pharmacy, Life Sciences, Business or Information Technology (or equivalent relevant professional experience).
  • Advanced to Fluent English language required. Multilingual skills desirable.
  • Proven technical aptitude and ability to quickly learn and use new software, regulations, and quality standards.
  • Advanced Microsoft Office Suite skills.
  • 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.
Working Habits
  • Able to navigate ambiguous situations and recognize when escalation/status updates are required.
  • Demonstrates domain expertise which drives execution in complex submission strategies.
  • Predicts and mitigates internal/external risks to the organization.

This is an equal opportunity employer that complies with all applicable equal employment opportunity legislation in each jurisdiction it operates.

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