Helen Hackett

Helen Hackett

Senior Manager, Regulatory Publishing

Key Knowledge Areas:

  • Document Compliance 
  • eCTD/NeeS Expertise
  • EU Procedures CP, MRP/DCP & National
  • US and RoW submissions
  • Electronic Submission Platforms: EMA & FDA Gateway, CESP
  • Regulatory Information Management Systems
  • Electronic Document Management and Tracking Systems
  • Validation software

Contacter

Helen has extensive experience in Regulatory Operations, gained over the past 13 years.   She has experience with multiple publishing and document management solutions and submission delivery strategies. 

Prior to joining BlueReg, Helen worked at PAREXEL as Principal Associate, Global Regulatory Outsourcing Services. During this time, Helen led projects managing the publishing and submission of global regulatory dossiers for multiple clients as well as resources, utilization and revenue forecast.

Prior to that, Helen was Regulatory Publishing and Operations Manager at Allergan and was responsible for the publishing and delivery of regulatory registration dossiers.

 

Helen joined BlueReg in 2018 as a senior regulatory publishing manager based in the UK.

Découvrez l'abonnement conseil bluereg