Freelancer profile translated to English.

Description

I help health companies bring their regulatory and quality projects to life with a pragmatic, independent, and results-oriented approach. My background has led me to work for over 15 years on both drugs and medical devices, from development to post-market, seeking the best balance between timelines, costs, and required standards.

Depending on the context, I act as a versatile problem-solver when a hands-on approach is needed, or I provide a broader perspective to step back and choose the most relevant option. I strive to tailor deliverables to the essential and propose concrete solutions for new situations. Furthermore, I enjoy sharing my experience with teams, with a genuine desire to enhance their skills.

✔ My role:

Secure your regulatory projects,
Optimize/build your quality processes
Accelerate your developments

✔ Pragmatic approach:

Identify what's essential to control your costs and meet your deadlines.

✔ My interventions:

Define product regulatory strategies;
Write regulatory dossiers (Marketing Authorization, Medical Devices and IVDR);
Bring your Quality Management Systems (QMS) into compliance;
Qualify and validate your manufacturing processes, sterilization, as well as your computerized systems and software;
Manage product compliance: deviations, changes, CAPA, complaints;
Train your teams on quality and regulatory requirements;
Support the development and evolution of your products and active substances;
Assist with transitions, crises, or peaks in activity, providing punctual support or interim management.

Industry field of expertise

Languages

French
Native or bilingual
English
Fluent

Workplace preferences

Can work on-site

Dijon (up to 50km), Lyon (up to 10km), Strasbourg (up to 50km), Paris (up to 50km), Tours (up to 50km)

MedDrugS Services
Regulatory Affairs & Quality Pharma and Medical Devices | CMC | ARE | QA | VSI | AQF | Qualif/ Valid
PHARMACEUTICALS INDUSTRY
April 2026 - Today (2 months)
Dijon, France
Regulatory affairs & quality missions for SMEs/mid-sized companies/pharma groups (human/veterinary/medical devices)
Regions covered: Bourgogne-Franche-Comté, Rhône-Alpes-Auvergne, Île-de-France, Pays de la Loire, Grand Est

Key skills: Regulatory strategy (MA/MD/IVDR/CMC), QMS/ISO 13485/ GMP/GDP, process/sterilization validation, interim management, product compliance (CAPA/deviations/changes)
Risk Analysis Marketing Authorization Technical File CMC Quality Assurance
Laboratoires Urgo
Quality Manager | Regulatory Compliance
PHARMACEUTICALS INDUSTRY
April 2017 - August 2025 (8 years and 4 months)
Chevigny-Saint-Sauveur, France
Human pharmaceuticals producing medical devices & drugs for its own account or for clients | Team: 5-6 people
•Reduced service budget by 20%through agile reorganization (without quality impact)
•Sustainably reduced the number of audit non-conformitieson critical processes
• **Proactive management of inspections/audits**: GMP, ISO 13485, MDSAP; preventive action plans deployed
• **Oversight of critical processes**: changes, document management, product compliance, QMS

Main missions:
Regulatory contact for Laboratoires URGO with its clients.
Site compliance: quality practices and documents/master manufacturing file aligned with client files/product standards.
Drafting/review of regulatory dossiers before submission to authorities by clients
Management of Change Control in interface with the 6 industrial sites (KPIs, facilitation)
Management of assigned changes, with responsibility for actions such as VSI/CSV, process validation as needed.
Quality Management and robustness of documentary compliance (master batch records, IT nomenclatures, analytical part).
Regulatory intelligence + benchmarking of industrial best practices.
Management of activities related to GMP site authorizations

Key skills: Management of GMP/MDSAP/ISO13485 inspections, multi-site Change Control, QMS optimization, regulatory intelligence, product/client compliance, GMP
Marketing Authorization Quality Assurance Change Management Compliance Audit
Laboratoires Urgo Healthcare
Regulatory Affairs Specialist (CMC) | Registration
MEDICAL
June 2015 - March 2017 (1 year and 9 months)
21300 Chenôve, France
Responsible for the regulatory portfolio of medical devices and drugs.

Concrete results:

*1 EU Marketing Authorization approvedwithin EMA deadlines

*17 CE certificationssuccessfully obtained (medical device manufacturing transfer).

*5 OOS resolutionswith in-depth investigations and effective action plans.
Design of studies and Type IA/IB/II variation strategies optimized for Marketing Authorizations & Medical Devices.
Drafting of dossiers + successful international submissions.

Main missions:
Single regulatory contact for portfolio products.
Alignment of studies with ICH requirements, standards, and guidelines.
Complete preparation of regulatory dossiers
Review of due diligence dossiers.
Timely submission of dossiers.

Key skills: CMC strategy, Type IA/IB/II variations, CE certifications, international submissions, regulatory due diligence.
Marketing Authorization CMC Regulatory Affairs Technical File Risk Analysis