CMC Specialist

Qualification:

• Higher education - pharmacist / physician / biotechnologist / chemist / biochemist

Knowledge:

• Knowledge of the structure, compilation particularities and life cycle of Dossier for the Drugs in CTD format.
• Knowledge of analytical methods of quality control of Drugs, Validation of analytical methods and technological process, bioequivalence / clinical trials / bio viewer procedures.
• Knowledge in the field of legislation, regulations governing the issues of registration / renewal, variations to Dossier of drugs.
• Experience of interaction with regulatory authorities in foreign markets and consultants / experts during registration / renewal /variation submission to Dossier of drug.
• English at upper-intermediate level.

Competencies Required:

• 3 year experience of work in R@D / QC / QA / RA.
• Experience in compilation Modules 2-3 of the registration dossier in Common Technical Document (CTD) format in English, Ukrainian and Russian and evaluation of 2,3,4,5 Modules in accordance with the requirements of regulatory authorities of different countries.