Regulatory Senior Manager

Job description

Senior Manager Regulatory – CMC


Looking for a permanent role? Want to work for a leading Pharmaceutical client? Reach out today!

Job responsibilities:       

  • You will direct resources and prioritize projects within the team to manage workload across submission management team in order to meet key deliverables across multiple customer including Manufacturing and Development
  • You will lead the team to deliver on communicated operational/ organisational targets
  • You will manage CMC submission management processes by leveraging expertise to optimize internal processes and tools
  • You will resolve process and/ or timeline issues across GRA CMC submission management
  • You will communicate issues to Director and CMC leadership as appropriate


Job requirements:

  • A BS or higher degree in a technical discipline such as chemistry, biology pharmacy or equivalent demonstrated
  • 5 – 7 years industry related experience
  • Knowledge/ awareness of agency submission procedures and practices and emerging submission electronic standards
  • Knowledge of drug development and / or manufacturing process


Additional skills/ preferences:

  • Demonstrated ability to operate and manage operational requirements in a regulated environment
  • Demonstrated expertise in developing and implementing process controls and system metrics

If you would like further information on this role, please send your CV to Louise Whitty or call 021 2359140

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