Leading Senior Director RA , Global, Amsterdam
For an International well known generic drug development company; I am looking for a Leading Senior RA Director.
This is a role for someone with ambitions to take their RA career to the next level.
You will be responsible for all the registrations on a global level.
In addition you will be leading the RA Team with a direct report line of 15 professionals.
- The approval of the product portfolio In Europe
- Prepare and execute operational and strategic plans in collaboration with cross functional teams
- Advise on Regulatory risks for operational plans and propose solutions.
- You will work closely with R&D in development of regulatory strategies for generics and new products as needed
- Responsible for development of RA standards and SOP's.
- Maintain Regulatory technical documents and ensure that they are up to date for compliance
- Lead the European Regulatory Affairs team
What we are looking for:
- You have at least 10 years Regulatory Affairs experience in the Pharmaceutical Industry
- You enjoy leading, developing and motivating the Regulatory Affairs team
- Excellent knowledge of ICH and EMA guidance on CMC
- Working experience with EU GMP, GDP and GCP guidelines
- Good knowledge of national and EU regulatory procedures
- Fluent in English; Dutch is desirable
If you are interested contact me directly on my number: +31651968847 or sent me your contact details: email@example.com and I will contact you within 24 hours.
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