Elaine O’Callaghan is Head of ePublishing within VCLS and responsible for the Global ePublishing team.
Elaine has over 8 years experience in ePublishing and developed the ePublishing group at VCLS. She provides assistance to International Clients with publishing strategy and submissions. She manages 50+ global applications including Initial MAAs, NDAs, BLAs, and INDs as well as LCM submissions, ASMFs and PSURs. She closely follows the evolution of eCTD and ICH guidelines and maintains VCLS’ internal eCTD Distinct Technical Procedures (DTP).
She is also responsible for the preparation, review and project management of MAA and LCM applications including communication with Competent Authorities, compilation of regulatory dossiers and the update of product information.
Elaine joined the VCLS Rennes office in 2006 and has since gained extensive experience in regulatory affairs, previously as Project Assistant and Regulatory Scientist. Her previous roles included assisting the project teams in the compilation of regulatory documents for submissions and providing administrative support such as ensuring the translation, printing, and shipping of documents for submission, proofreading and formatting regulatory documents and organising project-related travel.
She gained previous experience as a Personal Assistant in various fields in Ireland, United Kingdom, and the U.S.A. She is of English mother-tongue and holds a RAPS Regulatory Affairs Certificate - Pharmaceuticals and a Diploma in Business Studies and French.