Verwachte opdrachtduur: 4 months contract, 40 hours/week starting ASAP, Amsterdam

Plaats/regio: Amsterdam

Profiel van het bedrijf: Pharma organization

Profiel van de opdracht: - Write and review of regulatory documentation in collaboration with key internal stakeholders (nonclinical, clinical, medical, pharmacovigilance functions, etc.) - Coordinate the preparation and the submission of paediatric investigation plans (PIP) for new indications (eg. CRSsNP). - Coordinate preparation of Clinical Trial Applications - Initiate and coordinate the preparation of the Product Marketing Authorization - Ensure RA activities & tracking in the system: DSURs, PSURs

Profiel van de manager: - Master degree in HLS - Experience in RA on European level - Ability to produce written and oral regulatory or scientific communications with clarity and accuracy - Sense of urgency & reporting - Fluent in English

Opmerkingen: Assignment applications open until 15/07

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