Colmar, Grand Est, France
PharmD since 2009, after a 10-years experience as a retail pharmacist, I performed a full reconversion. I am now Quality Assurance & Regulatory Affairs Manager at PPRS Research, thanks to my experiences acquired in different types of Pharmaceutical companies (medical devices, innovative medicines, veterinary drugs and animal feed supplements). In addition to that, I developped my own business, as a consultant to broaden my experiences.
In charge of Medical Device Regulatory Affairs, Quality, and company Quality Assurance management. * Medical Devices, software, and Innovative Solutions: - FDA 510(k) submission - Knowledge of EU Medical Devices standards and references (incl. gap analysis) : MDD, MDR 2017/745, NF EN ISO 9001, NF EN ISO 13485, NF EN ISO 14971, - Validation of labeling FDA & FCC compliant, - Risk analysis management, - Materiovigilance management, - Regulatory intelligence follow-up. * Process manager Quality Assurance - development and maintenance of Quality system: - Establishment of Regulatory Affairs Strategy, - Redaction and animation of training modules, - Internal, external audit and inspection management, - Non conformities management, - Quality action plans, CAPA, CC, Management Review planification, - RGPD, CNIL, PIA actions set up.
Pharmaceutical consulting, staff training, strategic support, Regulatory Affairs and Quality Assurance.
Person in charge (PR) Regulatory Affairs, Pharmacovigilance and Quality - Pharmaceutical lab (human medicines): - Control and approval of medical promotion, Visa ANSM; - DMOS; - Staff training and evaluation; - Pharmacovigilance, EU QPPV; - Qualiopi certification in progress (2022).
Consulting support for product launch - Companion animal feed supplement company - Innovative dogs and cats feed supplement launch regulatory affairs strategy proposition; - Claims and packaging review.
“Veterinary Drugs” (M2 Strasbourg) and “Marketing Authorization Variations” (M1 Besançon) courses: set up course content, design of teaching material, courses, support of students, Q&A, exams.
“Veterinary Drugs” (M2 Strasbourg) and “Marketing Authorization Variations” (M1 Besançon) courses: set up course content, design of teaching material, courses, support of students, Q&A, exams.
• Marketing Authorisation Applications & Life-Cycle management of product portfolio in FR & LU (registrations, renewals, variations, national phases, regulatory declarations…); • Successful launch of an innovative antiparasitic solution, aimed to become one of the top antiparasitic medicines for cats; • Advertisement and communication tools validation and improvement (drugs and feeds); • Regulatory management: Procedures, New Vet Regulation strategy, company representation & relations with National Authorities and representative associations (SIMV), monitoring; • Labeling and packaging material translation, validation, submission; • Cross-functional support: clinical trials dossiers, management of biocidal portfolio, product’s regulatory assessment for organic farming, quality audits.