Senior CMC Officer

2 days ago

Athens, Attica, Greece JUST ONE | Recruitment & Executive Search agency Full time
  • 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

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