Unlock this candidate profile
Sign up free as a recruiter to view the full CV, contact info and reach out to this candidate.
Skills
Experience
Regulatory Affairs & Pricing Specialist
2019-12 - 2021-10
Led the preparation of value‑proposition dossiers for product registration and pricing submissions, ensuring compliance with local regulations. Conducted competitive intelligence analyses to inform pricing strategy and market positioning. Coordinated with the Ministry of Health on partnership projects, including screening programs and digital solution implementation. Delivered presentations at national and international conferences, enhancing company visibility. Achieved successful market entry for multiple pharmaceutical products.
Regulatory Affairs & Pharmacovigilance Manager (Freelance)
2019-04 - 2019-11
Provided independent regulatory and pharmacovigilance support to biotech clients, preparing submission dossiers and safety reports. Implemented risk management plans and monitored adverse event reporting in compliance with local and international guidelines. Managed small cross‑functional teams of 3‑5 specialists to deliver timely regulatory filings. Facilitated communication between clients and health authorities, reducing approval timelines.
Regulatory Affairs & Pharmacovigilance Manager
2017-07 - 2019-03
Oversaw regulatory affairs and pharmacovigilance activities for a multinational pharmaceutical portfolio. Directed a team of 6 professionals, coordinating dossier preparation, safety monitoring, and post‑marketing surveillance. Established partnerships with the Ministry of Health for national health initiatives, including digital health solutions. Conducted socio‑economic studies, notably on HER2‑positive breast cancer, influencing pricing and reimbursement decisions.
Technical & Regulatory Affairs Manager
2014-08 - 2017-06
Managed technical and regulatory affairs for new product launches, ensuring alignment with local regulatory requirements. Led cross‑functional project teams of up to 8 members, delivering regulatory submissions on schedule. Organized market access events for Roche and represented the company at international conferences. Developed digital tools to streamline regulatory documentation processes.
Technical & Regulatory Affairs Associate
2013-01 - 2014-07
Supported senior managers in preparing regulatory dossiers and conducting market access analyses. Assisted in the creation of value‑proposition documents and pricing strategies. Participated in collaborative projects with health authorities, contributing to the design of screening programs and digital health initiatives.
Pharmacist Assistant
2010-10 - 2012-12
Provided pharmacy services, including medication dispensing and patient counseling. Assisted in inventory management and ensured compliance with pharmaceutical regulations. Supported senior pharmacists in preparing documentation for regulatory inspections.
Languages
Francais
fluent
Last updated: 1 day ago