Leading Senior Director RA , Global, Amsterdam

Location
Amsterdam
Salary
Up to €120000 per annum
Posted
Jan 04, 2021
Closes
Feb 03, 2021
Ref
DB271997.2
Contact
Debie Biharie
Jobseeker Type
Professional
Organization Type
Corporate
Contract Type
Employee
Hours
Full Time

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.

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