Are you the CMC Regulatory Manager we’re looking for?
We offer a job as a CMC Regulatory Affairs manager, in which you will:
- optimally use your MSc/PhD (in Pharmacy, Chemistry or Life Sciences) and interest in drug manufacturing and the control strategies for it
- work in an international environment of pharmaceutical industry, with focus on Chemistry Manufacturing and Control
- review reports on pharmaceutical product and process development
- “translate” scientific lab results into regulatory supportive dossier documents
- prepare and coordinate regulatory submissions and marketing authorisation procedures
- stay up to date with literature and guidelines
- be coached by Zwiers
- an MSc/PhD in Pharmacy, Chemistry, Life Sciences
- (scientific and technical) writing and editing skills (English)
- knowledge of/affinity with analytical procedures, specifications, validation methods, stability testing, process controls etc.
- the eagerness to learn, develop and excel
- the ability to handle stringent deadlines
- the ability to communicate in a convincing way
Salary will depend on education, knowledge and experience
For further information you can contact Alex Zwiers, CEO, at tel. +31 (0) 610489150.