Our client is a professional Pharmaceutical organization, based in Noord-Holland Netherlands.
The company is an international orientated pharmaceutical company with a large drug portfolio in different therapeutic areas
You will be responsible for writing scientific documents and regulatory reports (MADs, IMPDs, Variations, etc.). You ensure full compliance with regulatory requirements. You are reporting to the Regulatory Affairs CMC Manager.
Analyze data scientifically and statistically
Write technical customer reports as well as CMC regulatory documentation
Solve problems and issues by offering practical solutions that are compliant with regulatory requirements
Follow-up on dossiers after submission
Remain up-to-date on all new laws and regulations concerning pharmaceuticals
You have a Masters degree in a chemical or pharmaceutical discipline (bio-engineer, pharmacist, chemist, ); a PhD degree is advantageous
You have experience with writing the CMC module of regulatory dossiers of chemical and/or biopharmaceutical drugs
You have excellent writing and presentation skills with attention to detail and accuracy
Youre able to handle multiple projects and to adapt to changing priorities
Youre a team player
Youre fluent in English
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