Regulatory Writer

I am currently supporting an independent agency who provide a full range of medical communication solutions, including regulatory writing services. They are currently seeking Regulatory Writers on a freelance basis to support them for up to 5 days per week on a 12-month contract. They can offer contracts between 3-5 days per week however; they would prefer consultants to work at least 4 days per week due to the workload they are currently maintaining. This position is fully remote so is open to all candidates based in Europe, for UK Candidate, this position is outside IR35.

Responsibilities:

• Support with the planning and delivery of regulatory submissions and other large regulatory projects
• Prepare clinical regulatory documents in a diverse range of therapy areas for their pharmaceutical clients
• Evaluate scientific data objectively, in order to describe results and scientific concepts in a concise and accurate manner

Requirements:

• Drug-development experience, relevant to the field of regulatory writing.
• Strong scientific background, including a minimum of a BSc (or equivalent) in an appropriate scientific discipline
• Good working understanding of clinical development and ICH guidelines for regulatory documents
• Authored a range of regulatory documentation including common technical document (CTD) modules, and regulatory briefing and response documents
• Experience of leading regulatory submissions is essential
• Experience of line management would be advantageous

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 contact me or have a look at available jobs on the Barrington James Website.

I look forward to hearing from you soon!

Jasmine Smith

Contract Consultant ~ Regulatory Affairs

+ 44 (0)1293 77 66 44