Head of Regulatory Affairs, Noord Holland
2 days left
- Experience Level
- Senior Management
For a well established Global Drug Development Company; I am looking for a Head of Regulatory Affairs for their operations in Europe.
This international growing company is mainly focused on development of Generic drug development.
With offices all over the world they are working on improvement of health and lifestyle by delivering highly quality human medical products.
In this role you will be leading a team of 15 RA professionals within the Netherlands & off location.
You will be responsible for the preparation and delivery of their Regulatory operational plans for their product portfolio in Europe.
This will be the ultimate career move for a Senior Regulatory Affairs professional with at least 10 years of experience who is ready for the professional step.
In this role you will be responsible for:
- 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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