Freelancer profile translated to English.
Back to original languageAbout Marie-Timothée
Doctor of Pharmacy, with 5 years of experience at LVMH for all the group's perfume & cosmetic brands, I have confirmed expertise in cosmetic and perfume regulatory affairs (including non-cosmetic products: candles, etc.).
I offer the following services:
- International regulatory analysis of your formula portfolios (Reg EC 1223/2009, IFRA, Prop 65, Canada Hot List, etc.)
- SDS writing
- Writing documents for your raw material suppliers
- Regulatory, toxicological and media risk assessment (Yuka, etc.) of your formulas.
- Assistance in developing formulation tools for perfumers as a "Product Owner" to define the needs of perfumers/noses/formulators.
- Renewal of your labeling with new allergens
- Writing a formulation charter according to your positioning
- Communicating international regulatory intelligence, anticipating changes and analyzing the impact
- E-commerce (Shopify): product submission, writing product descriptions, INCI list analysis, etc.
Rigorous, structured and autonomous, I integrate easily into teams, and I can be involved in one-off or long-term missions, remotely or on-site, to help companies ensure the compliance, safety and success of their projects.
French
Native or bilingual
English
Fluent
Can work on-site
Bordeaux (up to 50km), Paris (up to 10km), Biarritz (up to 30km)
Experience
- ANSM - Resah SIProject Coordinator Assessor - Solid OncologyPHARMACEUTICALS INDUSTRYMarch 2020 - February 2021 (11 months)Paris, France- Regulatory management of clinical trials: admissibility, clinical evaluation, and monitoring of substantial modifications- Monitoring of centralized MAA procedures (new MAA, renewal, variations, SmPC translation): adherence to the CHMP calendar and monitoring of country comments- Promotional review: validation of promotional materials
- LVMH Recherche – Direction ScientifiqueRegulatory Affairs & Public AffairsFASHION AND COSMETICSFebruary 2021 - February 2025 (4 years)Paris, France- Support for the regulatory teams of LVMH perfume houses in complying with European regulations (Reg EC No. 1223/2009, No. 1272/2008 CLP, 1907/2006 REACH, etc.) and international standards (Proposition 65, IFRA, CSCP, AICIS, K-REACH, K-CLP, DSL, etc.).- Lobbying: Active participation in working groups to defend industrial interests with the European Commission or other authorities/bodies (NMPA, FDA, PCPC, etc.)- Centralization of regulatory alerts from different geographical areas, risk definition, business impact analysis, and strategy sharing with LVMH Houses- Implementation of internal guidelines and specifications for perfumery raw materials to anticipate regulatory, toxicological, and media risks- Partner management (interviews and provision of support materials for suppliers, etc.)- Participation as a Business Expert ("Product Owner") in the creation of a new IT tool to aid in the creation of perfume formulas- LVMH representative within working groups (Cosmetics Europe, FEBEA) & animation of regulatory conferences- Writing regulatory certificates
- PCI Services Pharma,Intern in Quality and Regulatory DepartmentPHARMACEUTICALS INDUSTRYApril 2019 - August 2019 (4 months)Tredegar, Wales, United Kingdom- Quality Missions: creation of a Drug Product File, writing of Work Instructions and the CTD (Module 3)- Regulatory Missions: regulatory monitoring (Brexit), guideline manipulation- Support in validating regulatory documents with the QP
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Education
- Doctor of PharmacyUniversity of Bordeaux & ANSM2021Thèse de Pharmacie
- Advanced Diploma in Pharmaceutical Sciences2019Diplôme de Formation Approfondie en Sciences Pharmaceutiques