Carl Guillemot
Angestellt, Consultant GxP Services, TentaConsult Pharma & Med GmbH - A Tentamus Company
Münster, Deutschland
Werdegang
Berufserfahrung von Carl Guillemot
Bis heute 9 Monate, seit Okt. 2023
Consultant GxP Services
TentaConsult Pharma & Med GmbH - A Tentamus Company8 Jahre und 11 Monate, Nov. 2014 - Sep. 2023
Regulatory Affairs Specialist - Medical Gases
Westfalen AGRegulatory affairs for the medical gases of the company (medicinal products and medical devices), e.g. maintenance activities, variations, etc. Involvement in Pharmcovigilance and Materiovigilance activities (SOPs, responsibilities, etc.). Participation to GMP audits and inspections. Participation to audits according to DIN EN ISO 13485. PRRC according to Art. 15 MDR. Informationsbeauftragter gem. § 74a AMG (German Medicinal Product Information Officer).
2 Jahre und 1 Monat, Okt. 2012 - Okt. 2014
Regulatory Affairs Manager
MedSkin Solutions Dr. Suwelack AGGeneral Regulatory Affairs (MAA, variations, maintenance), in EU, USA + further individual countries, for medical devices & cosmetics. Risk Management (ISO 14971). Medical devices manufactured with tissues of animal origin (Commission Regulation 722/2012). Successful TSE-CEP application @ EDQM. Preparation of a Site Master File (SMF) for application purposes.
11 Jahre und 2 Monate, Aug. 2001 - Sep. 2012
Regulatory Affairs Manager and Consultant
DiaMed Beratungsgesellschaft für pharmazeutische Unternehmen mbH
General Drug Regulatory Affairs in Germany and other EU countries. Regulatory intelligence/strategy. Writing of CTD modules 2.3 and 3, and IMPD/IB. Preparation, compilation as eCTD, submission of MAAs/variations/reply to deficiency letters under consideration of the valid procedural rules. Project management.
Project assissant.
Ausbildung von Carl Guillemot
11 Monate, Sep. 1998 - Juli 1999
Cell- und Molekularbiologie
Université de Nantes (Nantes, France)
1 Jahr und 11 Monate, Sep. 1996 - Juli 1998
Pflanzliche Biotechnologie
Institut Unsiversitaire Professionnalisé (Toulouse, France)
1 Jahr und 11 Monate, Sep. 1994 - Juli 1996
Biologie
Institut Catholique de l'Ouest (Angers, France)
Sprachen
Deutsch
Muttersprache
Französisch
Muttersprache
Englisch
Fließend