Ireland
Regulatory Affairs Professional at Independent
Pharmaceuticals
Education
Royal College of Surgeons Ireland 2005 — 2007
Master's Degree, Industrial Pharmacy, Second Class Honour
Athlone Institute of Technology 1992 — 1993
Diploma, Business French
University College Dublin 1985 — 1989
M.Sc., Agricultural Chemistry
University College Dublin 1984 — 1985
H.Dip., Education
University College Dublin 1980 — 1984
B.Sc. (Hons), Biochemistry, 2.2
Experience
Alkermes Pharma Inc, 2011 - 2014
Elan Pharma Ltd, 2007 - 2011
Elan Pharma Ltd 1999 - 2007
Elan Pharmaceutical Research Corporation December 1994 - December 1998
Elan Pharma Ltd May 1990 - December 1994
Skills
CAPA, Clinical Research, Pharmaceutical Industry, Solida OraL Dosage Forms, Maintenance of Site..., Technology Transfer, Formulation Development, IMPD, Change Control, Patent, Lifesciences, FDA, Liquid dosage forms, QP Qualification, Regulatory Intelligence, Training, EMA, GMP, Sop, GLP, SOP, Stability Reviews, Project Team Support, Literature Reviews, Pharmacovigillance, Quality System, eCTD, Regulatory Affairs, Biotechnology, Clinical Trials, Clinical Development, Validation, Analytical Chemistry, Supplier Contract..., CMC, Regulatory Submissions, Biopharmaceuticals, Contract Reviews, Packaging Artwork, Regulatory Requirements, Medical Devices, Audit Support, Medical Writing, 21 CFR Part 11, Client Liason, IND