Overview
Senior CMC Officer Jobs in Athens, Attiki, Greece at JUST ONE
Title: Senior CMC Officer
Company: JUST ONE
Location: Athens, Attiki, Greece
Lead and coordinate CMC activities for pharmaceutical development projects, from early-stage formulation through to registration
Develop and implement CMC strategies aligned with product development timelines and EU regulatory requirements (EMA, ICH, etc.)
Prepare, review and manage high-quality CMC documentation for regulatory submissions (e.g., IMPD, MAA, variations, renewals)
Evaluate and ensure the suitability of active pharmaceutical ingredients (APIs) for use in new product development, including assessment of source, quality, regulatory status, and compliance with specifications
Collaborate closely with Formulation, Analytical, Quality Assurance, and Regulatory Affairs teams
Support technology transfer, scale-up, and validation activities in cooperation with internal and external stakeholders
Interact with external partners such as CMOs and CROs to monitor and manage outsourced CMC-related tasks
Monitor regulatory trends and updates in CMC guidelines and proactively integrate changes into development strategies
Requirements
BSc, in Chemistry, Pharmacy or a related field (MSc will be considered advantage)
At least 5 years of relevant experience in CMC, preferably in an R&D setting
In-depth knowledge of EU regulatory framework and CMC dossier requirements
Strong experience in preparing and reviewing CMC sections of regulatory documents
Excellent organizational and time-management skills
Fluent in English, both written and spoken
Ability to work independently while effectively collaborating in cross-functional teams
Good Microsoft 365/Office skills
Benefits
Private Insurance
Extra company benefits
