CMC Program Lead for Complex bRo5 Molecules

OverviewWe are seeking a Project Manager to join our team who specializes in Beyond Rule of 5 (bRo5) molecules and can lead cross-functional CMC development programs for complex, non-traditional small molecules.This role is central to coordinating technical strategy, timelines, and execution across discovery, development, and manufacturing for challenging...

Created in 2014, Excelya is a people-centered Contract Research Organization (CRO) that excels with care. We offer a personal and authentic experience within a young, ambitious health company on the path to becoming the clinical research leader in Europe thanks to our 800 Excelyates. Our unique one-stop provider service model - leveraging full-service,...

A leading pharmaceutical company is seeking a Senior Manager for CMC Regulatory Strategy Biologics. This role involves developing and executing CMC regulatory strategies for product lifecycle management. Responsibilities include leading dossier preparation, engaging with regulatory authorities, and coaching junior staff. Candidates should have 8-10 years of...

Responsibilities **Mission**: To manage the tracking, review and approval of RtQ including the management of all documents through the document management system for a small mocule in Oncoloy. Small molecule background desirable. **Activities and responsibilities**: Use existing tracker created for the filing of the dossier of a small mocule in Oncoloy to...

Prise de poste non définie Pharmaciens Paris Nombre de postes non défini CDI Rémunération non définie **Description du poste et des missions**: **Poste** Pharmacien affaires réglementaires CMC senior **Mission** - Diriger la stratégie réglementaire CMC pour toutes les activités post-approbation de l'actif, en fournissant des conseils proactifs...

As a **Global CMC Project Manager**, you will play a pivotal role in driving the operational execution of Chemistry, Manufacturing, and Controls (CMC) activities across the drug development lifecycle. Acting as the central hub between cross-functional teams, you will ensure alignment with strategic objectives, facilitate decision-making, and oversee the...

**Entreprise**: Our client, a gene therapy biotech, spin-off of Genethon, is searching for his/her CMC Operational Manager. **Poste**: Within a high growth, fast paced small organization, the CMC Analytical Scientist is responsible for providing analytical expertise and leadership in the development and manufacturing of recombinant - adeno associated virus...

Job TitleSenior Manager, CMC Regulatory Strategy BiologicsDivision / FunctionGlobal Regulatory Affairs (GRA)Manager’s Job TitleDirector/Sr Director CMC Regulatory Strategy BiologicsLocationParis, FR & Paddington, UKJob SummaryResponsible for developing and executing CMC regulatory strategy across product lifecycle—from early clinical trials to marketing...

Amarylys recherche pour l'un de ses clients, un(e) **Assistant CMC** Vous êtes à la recherche d'une nouvelle aventure ? Alors n'hésitez pas à postuler dès maintenant ! Démarrage Asap Localisation : Sud-ouest de l'Île-de-France Rattaché(e) à la division CMC Règlementaire au sein de la maison mère, vous travaillerez en étroite collaboration...

Are you a seasoned SDTM programmer, looking to make a significant impact on the world of pharmaceutical research? Do you thrive in a dynamic environment where your skills are recognized and your expertise shapes the future of clinical data standards? If so, I have an exceptional opportunity for you! They are at the forefront of revolutionizing the...