Senior Regulatory Affairs Specialist in Leiden fulltime ZZP / freelancer
Janssen Vaccines & Prevention B.V., previously Crucell, is one of the Janssen Pharmaceutical Companies of Johnson & Johnson. They are dedicated to bringing life-saving innovation to global health.
The teams focus on the discovery, development, manufacturing, and marketing of vaccines to protect people worldwide from infectious diseases. With the leading R&D group within the Dutch Pharmaceutical industry, they are in an outstanding position to commercialize several vaccines in the near future. This gives excellent personal development opportunities!
In the Senior Regulatory Affairs Specialist role you will:
Contributes to dossier strategy/complex product development plan creation at a compound level and to limited degree at a functional level;
Communicates and executes dossier strategy/product development plan with high level of autonomy and accountability;
Direct responsibility for project budgets;
Leads and supervises dossier authoring activities for early and late stage projects with limited or no guidance from manager;
Combines technical expertise with management skills. May select and manage external consultants;
Manages several complex projects with potentially accelerated priority or leads complex Phase 3 clinical programs;
Acts as a mentor to one or more individuals;
May coach project teams.
To qualify for the Senior Regulatory Affairs Specialist role you must have completed a PhD with Post-doc experience with 6+ years relevant experience or alternatively a Master degree with 8+ years relevant experience. You are fluent in English and quickly fulltime available. You are an EU citizen (MUST) and live in commuting distance from Leiden.
This is a fulltime contracting role through Herakles until the end of the year. The maximum hourly rate is € 110 all-in (ex VAT).
Interested in this Regulatory Affairs Specialist position? Please apply through this website. If you have any questions please reach out the person mentioned below.
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