Regina Dawkins

Director/Practice Area Lead - Quality Management and Compliance

Pharmalex UK

Biography

Experienced Director with 30 years in the pharma industry, working across the UK and Ireland with a wealth of experience and knowledge in the fields of API’s, Manufacturing (Commercial and Development across various product forms), Storage, Distribution and Transportation. Excellent knowledge of outsourced and global supply chains. Responsible Person on Wholesale Dealers Authorisation in both UK and Ireland. Responsible Person for Import on UK Wholesale Dealers Authorisations.
Excellent knowledge of UK, EU and US GMP and Controlled Substance regulations.
Proven track record of partnering with third parties incorporating relationship management and development of mutually acceptable compliance goals. Strong capabilities in the performance of compliance evaluations and risk assessments on complex GMP and GDP related issues. Knowledge and experience of supporting product launches in Russian/CIS countries, Brazil, China, Korea, Europe, US and MENA countries.