CMC Regulatory Affairs Officer M/F - CDI

Do you want to participate in the development of a French family-owned company, a major player in healthcare? Do you want to join a dynamic operational team within a growing company with significant industrial investments? Join us as CMC Regulatory Affairs Officer M/F A responsible and committed company, the Panpharma Group specializes in mature injectable medicines used in hospitals. By joining the Panpharma Group, you can be proud to contribute directly to its mission: Acting together, every day, to guarantee patients reliable access to essential medicines. You will participate in manufacturing injectable medicines every day that help treat and save lives worldwide. Through three production sites in France and Germany, the Panpharma Group has recognized expertise in the development, manufacture, and distribution of injectable medicines. As part of a replacement, we are recruiting a CMC Regulatory Affairs Officer M/F for our Saint-Cloud site. As a regulatory affairs officer, you will play a key role in the Group's development. Your main missions will be as follows: The drafting of administrative and quality modules (modules 1, 2.3 and 3) for MAA dossiers and their variations;

The monitoring of registration dossiers and regulatory variations until their approval in Europe and UK (national and European procedures);

Marketing authorization renewal operations;

The preparation, submission, and obtaining of approval dossiers for collective bodies;

The evaluation of regulatory needs within the framework of the development and/or marketing of new specialties;

The audit of DMF-type dossiers or MAA dossiers.

Cross-functional project management.

To successfully carry out these missions, you will work in direct contact with active substance manufacturers, internal and subcontracted production sites, business experts, and Regulatory Authorities. You preferably possess a Pharmacist degree (industry option) and/or a scientific BAC +5 or Master's in Regulatory Affairs, combined with a minimum of 5 years of experience in European Regulatory Affairs or CMC (including responsibility for the drafting part: modules 1 to 3) within a pharmaceutical laboratory of a similar size to Panpharma. You wish to work within a human-sized company where your ability to propose ideas, your autonomy, and your flexibility will allow you to integrate quickly. A fluent level of English is indispensable. CDI position based in Luitré-Dompierre (35), Beignon (56) or in St Cloud (92). We offer you the opportunity to develop your skills within a dynamic company, with a policy focused on supporting its employees and in a team united around common objectives. You will benefit from an integration program for your job developed by your Manager.

Your compensation package 13-month remuneration;

Meal vouchers with a value of €10, with 60% coverage by the company;

Company health insurance: unique scheme and 90% covered by the company for the whole family, with a very high level of overall coverage;

Unique provident scheme;

Profit-sharing agreement;

A dynamic social and economic committee (holiday vouchers, sports subsidies, preferential rates...). </body>