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Senior Manager Regulatory Affair, Global CMC

  • Job type: Permanent
  • Location: Dublin
  • Salary: Competitive
  • Job reference: Snr Reg Manager
  • Sector: EPM Scientific, Regulatory
  • Date posted: 31/08/2017
Senior Manager of Regulatory Affairs


The Company


 


My Client is a world leading biopharmaceutical company which specializes of identifying, developing and commercializing pharmaceutical products. In 2017, they are rapidly expanding and their current facility in Dublin is currently acting as the Global Headquarters.


 


The Role


Senior Manager of Regulatory Affairs


 


Participate and support as an active member of a multi-disciplinary team to establish Regulatory CMC strategies for commercial products, late and early stage development programs, under the supervision of GRA-CMC leadership. Through the performance of risk assessments, work with GRA-CMC leadership to identify and communicate potential risks associated with strategy scenarios to a multi-disciplinary team. Support EU, US and global clinical trials and commercial license maintenance. Coordinate the preparation and timely submission of responses to regulatory agencies. Manage time lines to ensure approvals are timely and development objectives are met. Act as regulatory CMC representative at meetings with business partners and regulatory agencies for CMC related issues.


 


Job Requirements


  • Established Regulatory CMC Background
  • Ability to adjust to new procedures/process quickly and effectively
  • Experience working with biologics or in an IMP environment is highly desirable
  • Fluent English essential
  • Extensive knowledge of GLP/GMP/GCP
  • A Degree in a scientific discipline or quality related field 
 



If this a position you are interested in, please submit a copy of your most up-to-date CV in Microsoft Word format to;


 


apply.a33ho1ghvac@epmscientific.aptrack.co.uk


 


Or Call;


 


+0044 203 758 8784


 


Nicky Walsh


Head of Quality Management for EPM Scientific, Ireland


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