working in a CRO i am the clinical Regulatory Affairs referent for european projects. i have a sound experience dealing with Clinical Trial Applications (cta) both to competent authorities (ca) and Ethics committees (ec). in my portfolio i have Phase I trials in france (sickle Cell disease, oncology), Phase II-iv in belgium, france, monaco, portugal, the netherlands and uk (oncology, Nephrology) and non interventional studies in austria, belgium, greece, italy, spain and uk. i am responsible of a broad range of activities starting with insuring the Regulatory Compliance of the science)" >Protocol, Informed Consent, labelling, and the completion of the eudract form. i also coordinate the completion of the cta dossier liaising with local CRA and sponsor and perform quantitative and qualitative Validation of the documents provided. my best asset is my deep knowledge and understanding of the new european ct regulation 536/2014 the development of which i closely follow.
Regulatory Affairs Consultant
Since January 2014
-Clinical Trial application (cta);
o experience in filling Clinical Trial Applications and amendments in europe with multicenter studies being key contact for austria, france, greece, spain, switzerland and uk. proficient using cta portals & tools (eudract, eudralink, iras);
o provide with filling strategies and sponsor's obligations summaries;
o contact with competent authorities and concerned bodies;
o preparing cta dossier;
o track project filling progress, budget and activities; report weekly to Project Manager
- prepare Training material and deliver it internally:
o Training on new regulation (eu) 536/2014
o european data protection directive 95/46/ec and local application in european countries.
-writing of internal sops, ra newsletter and perform regulatory watch
-prepare quotations, and business proposals
-Clinical Trial Application (CTA);
o Experience in filling Clinical Trial Applications and amendments in Europe with multicenter studies being key contact for Austria, France, Greece, Spain, Switzerland and UK. Proficient using CTA portals & tools (EudraCT, Eudralink, IRAS);
o Provide with filling strategies and sponsor's obligations summaries;
o Review of study essential documents to insure compliance (protocol, informed consent, labelling);
o Contact with competent authorities and concerned bodies;
o Preparing CTA dossier;
o Track project filling progress, budget and activities; report weekly to Project Manager
- Prepare training material and deliver it internally:
o Training on new Regulation (EU) 536/2014
o European Data Protection Directive 95/46/EC and local application in European countries.
-Writing of internal SOPs, RA newsletter and perform Regulatory Watch
-Prepare quotations, and business proposals
Senior Analytical Chemist Seneffe, BelgiumJuly 2009 --- March 2013
- liaise with different analytical and technical specialist, propose and coordinate Testing, review final analytical report for submission to reach. -write activity reports and highlights from the gc and GC-MS team, develop “5 years plan” for instrumental capability and swot Analysis. - reinforce safety and 5S attitude within the team, facilitate and support standardization of activities. - act as analytical key contact for a selection of internal business. product Analysis consultancy and feasibility with the writing of technical reports. - maintain regular contact with gc global internal community (share and learn) contributing to community of practice meetings. - keep knowledge in a breath of techniques being back-up Analyst for gpc and µir.
Analytical Chemist Cardiff, United KingdomFebruary 2004 --- June 2009
- characterize new and existing materials using a breath of Analytical techniques. - write analytical reports. - use existing methods or develop new when required (not fully validated methods). - hands on experience in gc-fid and GC-MS, gpc/sec conventional and triple detection, HPLC with UV (single and pda) and lsd, tga, dsc, ir and µir, xrf, NMR (29si, 1h, 13c).
in Clinical Research from Cefochim in 2014
Master of Science (MSc) in Chemistry from Universidad de Valencia in 2003
Research Project in Analytical Chemistry from Universitatea din București / University of Bucharest in 2001
in from CEFOCHIM in 0000