Prepares and/or manages MA submissions, able to participate on preparation of local administrative documents for submission, QC/compilation and/or ad hoc regulatory advice on submission packages within post-authorisation stage of the medicinal product lifecycle;
Reviews and/or provides linguistic input on local Product Information and Mock-ups;
Can act as contact point for RA matters for NCA and/or clients;
Involved in project management of the network of local contact persons for Regulatory affairs;
Manages collection and processing of RA Regulatory Intelligence;
Contributes to the proposal of market authorization strategy for clients;
Able to deputise for line manager.
University education in Natural Sciences, Chemistry, Medicine, Pharmacy or Pharmacology;
Previous industry experience is essential;
Knowledge of Regulatory area and applicable legal and other requirements (both local and global) within pharmaceutical industry;
Advanced knowledge of English (both written and verbal);
Experience with centralised procedures advantageous;
Experience with regulatory databases and dossier management software advantageous.