Regulatory Affairs Expert

I am working with a Biotech company based in Denmark that requires a freelance Regulatory Affairs Expert to work with them onsite for 6 months. This professional will be there to support the Regulatory Director in executing the regulatory activities to obtain marketing authorizations globally.

Responsibilities include:

• Provide regulatory expertise and strategy
• Prepare and communicate regulatory strategic and operational plans for assigned projects
• Support and deliver quality regulatory submissions in line with the applicable regulations, directives and guidelines, and in line with agreed strategies and timelines
• Ensure that all documents and information are adequately captured in a timely fashion

Suitable candidates will have:

• 5-10 years’ experience in EU regional regulatory procedures and legislation related to drug development and clinical trial applications
• Strong Project planning and management skills, being able to perform risk assessments, anticipating problems and providing creative solutions
• Experience in MAA submissions
• Based in Denmark

I specialise in recruiting Regulatory Affairs professionals throughout Europe, if you would like to speak to me regarding the above position then please call me today on +44 (0)1293 77 66 44 for a confidential discussion.

Alternatively you can reach me on Linked In or e-mail me on JASmith@barringtonjames.com.

If you are interested in discussing any of my other vacancies, or simply want to be made aware of opportunities as they arise then please reach out today.

I look forward to hearing from you soon!

Jasmine Smith

Contract Consultant ~ Regulatory Affairs

+ 44 (0)1293 77 66 44