Regulatory Affairs Senior Manager – CMC 12 month contract

The opportunity to work with a vibrant, global Bio-pharmaceutical company has become available. Our Client is urgently seeking an experienced Regulatory Affairs professional to work with them on a 12 month contract with the ability to work remotely 2 days a week.

Job Type: contract
Job Category: Regulatory Affairs
Region: Europe
Area: Switzerland
Location: Unspecified
Salary: Competitive Salary
Posted: 24th June 2019
Ref: JS2406

The opportunity to work with a vibrant, global Bio-pharmaceutical company has become available. Our Client is urgently seeking an experienced Regulatory Affairs professional to work with them on a 12 month contract with the ability to work remotely 2 days a week. Remaining 3 days will be based onsite at their office in Switzerland, near Lausanne.

Responsibilities include:

  • Provide support and report to Global Regulatory CMC Lead
  • Advise on country regulatory requirements in connection with the preparation of regulatory submissions
  • Ensure compliance of GMP documentation with regulatory modules
  • Coordinate collection of documents from site to ensure submission readiness
  • Perform reviews for global CMC submissions (MAA/BLA), responses to Health Authorities and life cycle management variations
  • Provide strategic and technical regulatory CMC expertise for new BLA/IND/IMPD/MAA applications, to support robust Module 3 Quality Sections

Suitable candidates will have:

  • A minimum of 5 years’ experience Regulatory Affairs CMC
  • Biologics experience (essential)
  • 7 years’ experience of industry experience
  • Degree in a Life Science or related discipline (minimum MSc or equivalent degree), higher degree preferable (e.g. PhD in a scientific discipline)

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

 

About Your Consultant

Email: fbrunner@barringtonjames.com Telephone: +41 417 693 093

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