Angers, Pays de la Loire, France
Pharmaceutical Consultant & Freelance medical writer/translator. 20 years of experience of drug development, regulatory affairs and pharmaceutical R&D Project Management
> Member of the Management Team. >Drive the formulation and anlaytical development of GlioCure's lead drug candidates towards GMP readiness for Phase I/II human clinical trials. > Advise on drug development, regulatory affairs and regulatory safety studies. > Write grant proposals (Horizon 2020; Merck BioTech Award; French Tech Seed, Sanofi iTech etc). > Help bring game-changing solutions to the market to effectively treat/cure Glioblastoma, and other aggressive cancers.
* Planning and execution of the full development of new veterinary medicinal products, from the Proof-of-Concept studies though to registration (EU, US, RoW). Specialities: Livestock reproduction; Anti-parasitics; production enhancement. * Working knowledge of all fields related to veterinary product development: pharmaceutical sciences; pre-clinical development; Human Food Safety; Environmental safety; Clinical Trials; Pharmaceutical Quality; Regulatory Affairs. * Project Management: Writing project proposals, including SWOT, IP and NPV analysis; Creation of project plans; Reporting, and management of information flow; Use of MS Project and Connectivity; Responsibility for between 1 to 2M$ of R&D spend per year; Presentations (internal & external). * Hierarchical and non-hierarchical management of multidisciplinary, multi-cultural R&D teams in a matrix environment. Approval & review of study protocols and reports (all fields). * Interaction with many parts of the company: marketing, legal, manufacturing; supply chain; R&D management; finance. * Regulatory affairs: Face-2-face meetings with health authorities for pre-development meetings, oral hearings (EU & US). Writing pharmaceutical expert reports. Responsibility for registration dossier consistency and content. * Responsable Pharmaceutique (QP) interimaire, for liberation of GMP clinical trial batches.
* Formulation and development of a wide range of novel veterinary pharmaceutical forms. Speciality: sterile forms and sustained release. Primary packaging selection. Supply for pre- clinical and clinical trials. Lab scale to pilot GMP manufacture. Transfer to production. * Development of a generic veterinary product. * Good working knowledge of pharmaceutical microbiology (bioburden-, endotoxin-, and sterility testing, viral safety) * Collaboration with analysts for elaboration of product specifications, and stability testing. * Multi-disciplinary team work with pre-clinicians, clinicians, project management, lab managers and technicians. * Regulatory affairs: Writing CMC / Part II sections (EU & US). Regulatory defence (CMC/Part II) for a portfolio of around 10 veterinary products, including full CMC dossier updates.