Regulatory Affairs Associate Director - 12 month contract

I am currently working with an innovative start up Biotechnology Company based in Germany, near Hamburg, that are seeking an experienced Regulatory Affairs Associate Director to work with them on a 12-month contract.

Responsibilities include:

• Provide support and report to the Regulatory Affairs Director including assisting with the regulatory strategy
• Provide strategic and technical regulatory CMC expertise for new BLA/IND/IMPD/MAA applications, to support robust Module 3 Quality Sections
• Advise on country regulatory requirements in connection with the preparation of regulatory submissions 
• Ensure compliance of GMP documentation with regulatory modules
• Perform reviews for CMC submissions (MAA/BLA)
• Point of contact with Regulatory Authorities

Suitable candidates will have:

• At least 7 years’ experience in Regulatory Affairs CMC
• Experience in Biosimilars/Biologics
• Life Science Degree (MSc or PhD)

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