Our client is a professional Pharmaceutical organization, based in Noord-Holland Netherlands.
I am looking for a Regulatory Affairs CMC specialist with FDA and EMA experience. My client is an international leading pharmaceutical company and they need a Freelance CMC specialist to support their team. You will support the Regulatory Affairs department with submissions to the FDA and EMA.
Will prepare the CMC documentation for international submissions in accordance with local requirements.
supervise the compilation of CMC dossiers.
Experience with several modules like 2 and 3.
Answer questions from health authorities and coordinate the response process;
You are conversant with relevant, worldwide registration requirements;
You are conversant with literature relevant to the projects and products;
You make proposals to the organization with regard to variations of chemical and pharmaceutical documents, following questions from authorities: Additionally you consult with the departments involved.
You take the initiative for and coordinate additional studies which are performed by the chemical and/or the pharmaceutical disciplines.
At least a MSc (in Pharmacy, Chemistry or equivalent) or a BSc with multiple years of experience Several years of experience in CMC. A pharmaceutical background. Good command of written and spoken English. Command of Dutch is an advantage Good social skills, communication skills and you are a team player. You have good organizational skills.
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