CMC Analytical Leader

Our client is an international pharmaceutical company developing novel therapeutic solutions to serve patient needs worldwide. With heavy investment in Research & Development activities, they collaborate with many partners from academic labs to start-ups, pharma and biotech companies to tackle health challenges.

Within the CMC and Analytical Development Department, they are currently looking for an experienced scientist following internal promotion. Using your solid analytical chemistry experience and hands-on background, you will manage studies and analytical development activities of NCE during clinical development phase or post marketing authorization.

Your main activities will include writing up & managing analytical protocols and reports to support development activities & studies set up. As an experienced Analytical Chemist, you’ll be the analytical point of contact for CMC group projects and manage the documentation aspects of analytical projects.

You will be responsible for writing up regulatory files (IMPD, IND, MAA, NDA) and answering questions from health authorities with the help of colleagues from the regulatory team.

The ideal candidate will have a BSc and/or MSc in Analytical Chemistry (or closely related field) and 8+ years relevant experience in analytical development and registration files redaction.

In order to be successful, you will have a solid background with analytical chemistry techniques & instruments (HPLC, dissolution, etc…) including method development experience in GMP regulated environments.

You will have strong organisation and communication skills and be a proactive person. Fluency in English is essential as all reports and files are written in English.

This is an exciting position in a growing international organisation and you will be rewarded with a generous salary, bonus and benefits package along with excellent career progression opportunities within the group.

Apply now to find out more about this role!

Keywords: pharma, pharmaceutical, regulatory files, IMPD, IND, NDA, MAA, investigational medicinal product dossier, investigational new drug, new drug application, writing up, registration files, HPLC, LC-MS, CMC, chromatography, analytical chemistry, GMP, BPF, Paris, Orleans, France, VRS8806FP