job CMC

of products in Europe and internationally - Drafting dossiers (including CMC updates), publishing and submitting them - Act... regulation - Proven experience in CMC and medical devices - Knowledge of DM regulations and quality standards: ISO 9001... - Voir cette offre d'emploi

of the CROs and working closely with other relevant team members involved in the study set up (DM, Reg, CMC etc…): ensure... - Voir cette offre d'emploi

Strategy, Regulatory Operations & Market Access, CMC & Quality, Non-Clinical and Clinical Development Strategy. Collaborating... - Voir cette offre d'emploi

global regulatory consulting services in the areas of Regulatory Strategy, Regulatory Operations & Market Access, CMC... - €150000 - 200000 per year - Voir cette offre d'emploi

. Main responsibilities / job expectations Project management responsibilities - Facilitate a cross functional CMC sub team, in charge... Clinical Supply Chain Therapeutic Area Lead - Develop strong collaboration with Global Regulatory Affairs and CMC Regulatory... - Voir cette offre d'emploi

of the CROs and working closely with other relevant team members involved in the study set up (DM, Reg, CMC etc…): ensure... - Voir cette offre d'emploi

, CMC Supply chain…) and SPs Establish and maintain excellent professional relationships with Services Providers, clinical... - Voir cette offre d'emploi

. Author CMC sections of regulatory dossiers/supporting information for post-approval changes and support regulatory compliance... - Voir cette offre d'emploi

. Author CMC sections of regulatory dossiers/supporting information for post-approval changes and support regulatory compliance... - Voir cette offre d'emploi

Heads, as well as Procurement, Legal and Regulatory/CMC teams. In addition, to ensure consistency and to support overall M... with Procurement, M&S Functions (API External Manufacturing, Supply Chain, Quality, HSE) and Regulatory/CMC to ensure timely selection... - Voir cette offre d'emploi