Beschreibung

Engineer in biochemistry with 7 years of experiences on a wide spectrum regulation (Cosmetics, Medical Device, Food Supplement) to ensure compliance from an End-to-End process for your products launches.

Detailed oriented, rigorous and organized to deliver within deadlines ensuring regulatory compliance

Ownership mindset, versatile profile, adapt and learn quickly to face challenges supporting the business

Collaborative way of working

Cross-functional interaction within international environment position

Branchenexpertise

Sprachen

Französisch
Muttersprachlich oder zweisprachig
Englisch
Verhandlungssicher

Arbeitsortpräferenzen

Nur remote

Führt Projekte hauptsächlich remote aus

Johnson & Johnson SBF/ KENVUE
Senior Regulatory Affairs Specialist EMEA
GESUNDHEIT & WELLNESS
August 2022 - Heute (3 Jahre und 10 Monate)
Issy-les-Moulineaux, Frankreich
Skin Health Regional Role (Neutrogena) & Essential Health Local Role (Vania/Nett)
Regulation : Cosmetics, Commodities & Medical Devices

REGULATORY AFFAIRS & PROJECT MANAGER
• Be the regulatory key contact during product development leading with strategic inputs among strong partnership with R&D, Marketing & local regulatory colleagues
• Build strong, innovative & competitive claims with a strategic risk based approach
• Contribute to claim & artwork process optimization to enhance efficiency and effectiveness at both regional and local role with consistency
• Communicate with all cross-functional partners to support and execute with excellence within deadlines
• Ensure composition, artworks, promotional materials compliance, PIF compilation
• Provide support & guidelines for Marketing team regarding science driven claims and environmental claims
• Support during challenges from Health Authority or internal audit within EMEA region
• Sustainability : AGEC french law implementation, understand challenges of new environnemental laws, close collaboration with packaging team

EU & NON-EU PRODUCTS REGISTRATION
• Support flawless regulatory submissions (FSC, GMP, product statement) within deadlines by anticipating and delevering robust registrations plans

EXTERNAL INFLUENCE
• Identify and assess key regulatory challenges having greatest impact on EMEA regulatory environment by participating in trade union meeting (FEBEA)
• Defend and shape regulation by representing Kenvue organization in trade association for femcare products (Group’Hygiène, EDANA)
GIPHAR GROUPE
Regulatory Affairs Project Manager Healthcare and Hygiene Products
GESUNDHEIT & WELLNESS
Januar 2019 - September 2022 (3 Jahre und 8 Monate)
Paris, Frankreich
Regulation : Cosmetics, Medical Devices & Food supplements

REGULATORY AFFAIRS & PROJECT MANAGER
• Ensuring regulatory compliance for all products distributed in the 1350 Giphar pharmacies from marketing brief to market launch (120 references)
• Creation of regulatory affairs framework for MD (DoC, EC Certificate, UDI code, ..)
• Coordination & internal training of transition from 93/42/CE Directive to 2017/745 Medical Device Regulation
• Development of Quality Specifications & Internal Quality Procedures
• Participation and monitoring of inspections by French Authorities
• Management of sanitary crisis on food supplement regarding ETO (Ethylene Oxyde)

EU REGISTRATION
• CPNP Notification (Cosmetic),Téléicare Notification (Food supplement) & ANSM Distribution submissions of Medical Devices

EXTERNAL INFLUENCE
• Regulatory monitoring (FEBEA), participation in the Chartres Congress
• Representing Giphar Groupe in the taskforce ACL-CIP/SNITEM
GIPHAR GROUPE
Cosmetic R&D Project Manager & Regulatory Affairs
September 2017 - Dezember 2018 (1 Jahr und 3 Monate)
• Coordination and management of new brand launch with 10 subcontractors
• Respect of planning, reporting, cost monitoring
• Validation formulas, claims, labelling, management of clinical trials
• PIF writing & CPNP notification
• Supervision of a Project Manager assistant