Cmc Regulatory Senior Specialist Lazio

Cmc Regulatory Senior Specialist
Roma
Lazio, Lazio

On behalf of our client - an important pharmaceutical group - we are looking for a CMC Regulatory Senior Specialist. This role ensures high-quality content for regulatory CMC documentation in line with applicable guidelines for new and approved Drug Products and/or Drug Substances of the Company Group in Europe, the USA, and other countries. Key Responsibilities: Authoring of CMC sections (Drug Product and/or Drug Substance) of the registration dossier for new applications in CTD format in line with the Global regulatory strategies and the most current regulatory guidelines. Authoring and review of CMC sections to support variations. Gap Analysis and/or Due Diligences of Quality Parts of Global Dossier(s). Ensure regulatory compliance of CMC sections of global products and drug substances throughout the product lifecycle. Evaluation of regulatory impact of quality change controls. Support to QA function during Health Authorities' inspections. Support to QA and Virtual Plant for Third parties Qualification (CMO). Publishing and/or creation of eCTD sequences related to CMC sections. This is a permanent role within the company production site in Frosinone. J-18808-Ljbffr