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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 lwhitty@sigmar.ie or call 021 2359140

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