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.

Responsibilities:

• 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: d.dries@nonstop-recruitment.com and I will contact you within 24 hours.