Current Role:
In his role as Regulatory Affairs Lead at Almac Pharma Services, David is involved in the licensing of new medicinal products, right from the beginning of development, through the whole application process and resulting in the UK approval of drugs. David reviews analytical testing reports for new medicinal products’ Marketing Authorisation applications and checks proposed changes to existing product licenses before they are implemented.
Previous Experience:
After graduating from Queen’s University Belfast with a Masters degree in Pharmacy, David completed his training as a Pharmacist with Alliance Boots. He worked as a Pharmacist Manager for the company for three years before joining Almac.
David has worked in the Scientific Affairs Department of Almac Group for over ten years. His experience encompasses development, pre-approval and post-approval regulatory activities. This includes the management of scientific advice meetings, compilation and submission of clinical trial applications, and the management, compilation and submission of new Marketing Authorisation applications for medicinal products in the EU.
David also has experience with the maintenance of INDs and NDAs for US drug products. He has prepared, submitted and maintained EU and US orphan designations, including managing pre-submission teleconferences with the European Medicines Agency and FDA.
David is a Member of the Pharmaceutical Society of Northern Ireland
Joined Almac:
2010
