MEDICAIR SA is now offering a great opportunity for career development and is seeking to hire a highly motivated and experienced Senior CMC Officer to join our R&D department.

The successful candidate will be responsible for overseeing all Chemistry, Manufacturing and Controls (CMC) activities related to the development of new products, ensuring compliance with EU regulatory requirements and supporting cross-functional collaboration across development, quality, and manufacturing teams.

Key Responsibilities:

• 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.

Qualifications:

• 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.

MEDICAIR offers competitive remuneration package, private insurance, work-life balance, continuous learning and development opportunities, and a fast-growing and friendly working environment.