Preparation of CMC documentation for international submissions
Review and release of CMC documents
Participation in project teams to provide regulatory input
Coordination of the agency response process and preparation of answers to questions from health authorities;
BSc, MSc or PhD in the area of (Analytical) Chemistry, Pharmacy or Biology
At least two years of relevant working experience (candidates with relevant research experience from an internship or candidates with a more senior profile are invited to apply as well)
At least one year of experience in regulatory affairs preferably in CMC is an advantage
Experience in biotech is an advantage;
Demonstrated editing skills
Outstanding interpersonal skills
Good oral and written communication skills in English
Knowledge of Dutch and/or other languages are preferred
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