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

Helen Hackett Senior Manager Regulatory Publishing

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 UK.