R&D CMC Officer
R&D CMC Officer
DEMO Pharmaceuticals
Athens, Greece
Description
At Demo SA, one of the world’s largest pharmaceutical manufacturers in injectable facilities, we are looking for a highly motivated and detail-oriented R&D CMC Officer to join our team.
Main duties and responsibilities:
- Prepare CMC technical documents in accordance with FDA requirements
- Collect and evaluate scientific data
- Conduct extensive literature research and studying of scientific documents
- Act as a liaison with Regulatory Teams
- Understand Regulatory strategy and documentation requirements
Requirements
Experience, skills and qualifications required:
- BSc Degree in Chemistry, Biology or relevant field.
- 1+ years of experience in CMC within a Pharmaceutical organization.
- Scientific/technical writing skills
- Fluent in English and good MS Office skills
- Strong organization skills, multi-tasking and able to meet deadlines
- Effective communication and relationship management
- Knowledge of GMP and CMC guidelines
- Ability to work under pressure, resilience
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