Freelancer profile translated to English.

Description

🧬 Regulatory & Market Strategy Consultant – EMA, National Submissions & Licensing

🧭 Who I am

Freelance consultant specializing in regulatory affairs and market access strategy in Europe. I support biotechs, medtechs, and veterinary laboratories in their registration processes (EMA & national) and their licensing-out / go-to-market strategy, in direct contact with authorities or in support of internal teams.

🔍 What I do

EMA Submissions (Articles 25 & 42, centralized procedure)

National procedures / DCP / MRP

Writing and review of eCTD dossiers (Modules 1 to 5)

Preparation for scientific and pre-submission meetings

Management of interactions with authorities: EMA, CHMP, CVMP, CMDv, ANSM, AEMPS, etc.

Coordination with experts QP / GCP / GMP / PV

Strategic analysis for licensing, regulatory valuation

Development of European market access strategies (Go-to-market)

💼 What I offer

Complete or partial management of your EMA or national submissions

Structuring of regulatory and commercial strategy from the early stage

Positioning audit for licensing-out or investment

Development of multinational registration plans

Support for structuring pitches / dossiers for partners

Analysis of medical and institutional receptivity (pricing, access, etc.)

✅ In summary

Trilingual (FR / EN / ES)

Proven experience in biotech, animal health, medtech, oncology, infectious diseases

Agile, autonomous, confidential format

References available upon request

Adapted to regulatory-driven and business-oriented environments

Industry field of expertise

Languages

French
Native or bilingual
Portuguese
Native or bilingual
English
Native or bilingual
Spanish
Fluent

Workplace preferences

Can work on-site

Grenoble (up to 50km)

Life Sciences Data
Strategic Analysis and Scientific Market Research Consultant – Targeted Oncology
BIOTECH
March 2025 - April 2025 (1 month)
Lyon, France
Conducted an in-depth market study on new approaches in oncology combining optimized chemotherapy and monoclonal antibodies (conjugated or ADCs – Antibody-Drug Conjugates).

Scientific and patent competition analysis:
Mapping of players involved (startups, big pharma, institutes), status of filed patents and products in development or marketed. Assessment of technological maturity and key differentiators.

Clinical acceptability and medical relevance:
Targeted interviews with oncologists, hematologists, and hospital researchers to assess interest, reluctance, and potential clinical uses. Identification of barriers to adoption, unmet needs, and therapeutic decision-making criteria.

Scientific and clinical impact assessment:
Detailed analysis of scientific publications (peer-reviewed journals, clinical trials, meta-analyses) to determine the robustness of clinical results, the added value of targeted approaches, and their potential to transform medical practice.

This study helped guide the strategic decisions of a biopharmaceutical company in the market positioning phase, by consolidating scientific evidence and clinical adoption signals.
Market Research Competitor Analysis Biotechnology Oncology Intellectual Property
Life Sciences Data
EMA Submission Manager | Centralized Proc. & Strategy
BIOTECH
January 2025 - Today (1 year and 7 months)
Client: European Biotech in EMA submission phase – innovative product (veterinary DNA vaccine)

Regulatory coordination mission for an MAA via EMA centralized procedure, within the framework of a submission under exceptional circumstances (Article 25).

My role covered all phases:

1. Preparation and submission of the eligibility dossier (Article 42)

2. Drafting and structuring of questions for the EMA (pre-submission meeting)

3. Coordination of interactions with regulatory experts (QP, GCP, GMP, etc.)

4. Preparation of the briefing package and documents for the pre-submission meeting

5. Support for submission strategy (choice of modules, alternative national procedures…)

6. Assembly of the complete dossier (SPC, application form, MRL, GMP procedure, etc.)

7. Planning of the submission and management of critical deadlines

Result: EMA eligibility for centralized procedure validated + organization of a submission under exceptional circumstances with documentation compliant with expectations.

➡️ Confidential mission conducted in English in an international context, interacting directly with authorities and regulatory partners
Life Sciences Data
Operational and Digital Transformation Consultant – Biobank & Laboratory
BIOTECH
April 2024 - June 2025 (1 year and 2 months)
Luxembourg, Luxembourg
I led a complete restructuring mission for a laboratory and a biobank, divided into three distinct phases:

Phase 1: Operational Diagnosis:
In-depth analysis of existing processes (from sample reception to processing and storage), identification of friction points, redundancies, and organizational weaknesses. Interviews with field teams, document review, assessment of compliance with quality and regulatory standards.

Phase 2: Benchmark and Competitive Analysis:
Detailed comparison with other equivalent European structures, including a benchmark of pricing practices (biobank/lab service pricing), digital tools used, and performance standards (processing time, traceability, productivity).

Phase 3: Implementation and Optimization:
Deployment of adapted digital tools (dashboards, traceability automation, quality monitoring modules), restructuring of critical processes, and definition of new, more efficient workflows. Team training and change management to ensure sustainable adoption of new practices.

This mission led to performance optimization, enhanced commercial attractiveness, and improved service quality and compliance.
Automation VBA Microsoft Excel Process Optimization Diagnosis