Regulatory CMC Scientist – 12 month contract

I am working with an international bio-pharmaceutical company based in the UK. My client is looking for a freelance Regulatory CMC Scientist to work with them onsite for 12 months. This professional will be responsible for regulatory CMC activities for all NCEs products.  

Key Responsibilities include, but are not limited to:

• Support of the development and implementation of the regional CMC Strategy and submission plans
• Writing regional and global CMC documentation for submissions 
• Support in the preparation of the CMC regulatory Risk Capture Document
• Point of contact with Health Authorities, supporting with responses and negotiating CMC approvals
• Provides regulatory assessments for CMC changes and creation of entries and updates in the designated systems

Suitable candidates will have:

• Life Science Degree
• 5+ years’ relevant experience in Regulatory Affairs CMC
• 3+ years’ experience in pharmaceutical manufacturing, analytical development and quality assurance
• Proven success in authoring and contributing to delivering CMC sections of marketing authorisations for new biological or chemical entities
• Registration experience from working in the pharmaceutical industry or a regulatory authority on development and post-approval products

A full job description is available upon application.

I specialise in recruiting Regulatory Affairs professionals throughout Europe, if you would like to speak to me regarding one of my current vacancies, or simply be made aware of opportunities as they arise then please call me today on +44 (0)1293 77 66 44 for a confidential discussion.

Alternatively e-mail me on JASmith@barringtonjames.com.

I look forward to hearing from you soon!

Jasmine Smith

Contract Consultant ~ Regulatory Affairs

+ 44 (0)1293 77 66 44