Becky Willoughby

Becky Willoughby

Senior Consultant, Regulatory Affairs

Key Knowledge Areas:

- EU/UK/IE Regulatory
- Lifecycle Management
- CMC dossier authoring
- Product Information
- eSubmissions
- Project Management

Becky has 12 years experience working within the pharmaceutical industry, with 10 years’ working within regulatory affairs and has experience spanning pre-registration through to post-approval across the Centralised, DCP/MRP and National procedures.

 

Prior to joining BlueReg Pharma Consulting, Becky has held various positions within regulatory affairs within the OTC, innovative and generic arenas.  She has several years experience within line management and has extensive project management experience.

 

Becky started her regulatory career in 2007 working within a small regulatory consultancy company Callisto Consulting where she was responsible for all post-approval regulatory activities for their main client, she was also responsible for all pharmacovigilance activities for all clients.

 

In 2009 Becky joined The Boots Company and worked with OTC products in all aspects of post-approval regulatory, during her time she led a project to set-up the company for submissions in eCTD with the support of 2 contractors, this project involved converting over 100 licences from NTA to CTD format. 

In 2013 she joined Archimedes Pharma Limited where she was responsible for all regulatory activities and worked on MRP/National and Centralised Procedure submissions. She also setup publishing capabilities in-house.

 

In 2014 Becky moved to Mylan where she was responsible for a team of regulatory officers and all post approval activities for MRP/DCP and CP products. During her time at Mylan she gained experience in submitting DCP MAAs and due-diligance activities. In 2017 Becky worked at Ethypharm UK Limited and was responsible for bringing all regulatory activities in-house from external contractors, this involved setting up all processes, SOPs and systems.

 

In May 2017, Becky moved to BlueReg Pharma Consulting.

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