Paula Buffery

Paula Buffery

Associate Director, Regulatory Affairs

Key Knowledge Areas:

  • European procedures
  • Global regulatory strategies
  • MAA submissions
  • Life cycle management
  • Scientific Advice
  • Due diligence

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About Paula

Paula has over 20 years’ global regulatory affairs experience in the pharmaceutical industry in a variety of companies and settings. She has subject matter expertise on a wide range of regulatory projects, including European procedures, global regulatory strategies and life cycle management.

 

Paula is a Fellow of TOPRA (The Organisation for Professionals in Regulatory Affairs) and has served on the Editorial Board of the Regulatory Rapporteur.

 

Paula joined BlueReg in 2019 as Associate Director, Regulatory Affairs and is based in the UK.

 

Background/Past experience

Paula has worked in regulatory affairs since 1999. Prior to joining BlueReg she managed her own business for over six years as a freelance consultant, with a focus on European procedures, life cycle management, due diligence and dossier conformance.

 

Prior to that Paula was a regulatory affairs consultant at UKR Regulatory Affairs Limited, a small consultancy based in the UK. At UKR, along with all regulatory activities, Paula was also involved with the operational management of running the business and lead the quality management.

 

Prior to that Paula was a manager at Shire Pharmaceuticals and a Senior Regulatory Affairs Officer at Mayne Pharma. In both positions Paula had extensive European procedure and life cycle management experience.