Regulatory and clinical affairs project manager based in south of France M / F. Job in Marseille 13013, Provence Alps Côte-D’azur France
Our client, is an innovative actor in the fine chemicals and pharmaceuticals sector, and is carrying a project with very high global stakes. That is why our client is looking for its regulatory and clinical affairs project manager based in France (Provence)M / F.
Directly reporting to the RD Director, within a team of two project managers, you will ensure the compliance of on-site manufactured pharmaceutical products according to the Good Manufacturing Practices (GMP) and the Public Health Code .
You will write the pharmaceutical part of the registration files and changes, in order to obtain and maintain the products’ market launches.
You will answer the regulatory authorities’ questions about the pharmaceutical section (Module 3) for Marketing Authorization dossiers.
Your main tasks are:
• Monitor and maintain marketing authorizations (renewals, variations, process requests, etc.) while ensuring compliance with concerned legislations,
• Lead the creation and the management of technical documents required for European regulatory and export registration files.
• Check the formulas’ validations and the entire legal markings on all packages.
• Complete the writing, filing and tracking of clinical records for their submission to various authorities: French Health Products Safety Agency (AFSSAPS), Ethics Committee, French Data Protection Authority (CNIL), The French National Medical Council (CNOM) ...
• Lead the clinical studies implementation and follow-up, in France and abroad,
• Complete the writing of the necessary documents for the tests (clinical study protocol, Operational Handbook, reports, patient questionnaire, specifications ...)
• Prepare specific regulatory applications (applications for clinical trials authorization, Temporary Use Authorisation (TUA), import requests ...)
• Provide a regulatory support to the different departments of the company for the products you are in charge of
You are involved in the group-project concerning the European and international procedures compliant registration of new products and carry out records audits about products acquisitions.
Graduated in pharmacy with a specialization in regulatory affairs or drugs development and international registration, you have a good knowledge of pharmaceuticals development and/or manufacturing, and the current regulations. Given the international context of this job, your English is fluent, and the fluency in a second language would be a plus.
Rigorous, curious, you have the taste for investigations, with good synthesis ability, you know how to anticipate and to adapt to strong growth company. Your high standards combined with an ability to question yourself when necessary, in order to upgrade the processes, and take initiatives according to your hierarchy. Enjoying team-work, you can handle several files simultaneously, and are solution-oriented in order to be effective in a constantly changing industrial environment. Your attention to detail, your awareness of ethics, and your communication skills are real assets for this position.
A Junior profile could suit this position.