Global Regulatory Scientist CMC: Biologics

Employer
Xplore Life Science
Location
Tregonhawke, UK
Salary
Competitive
Closing date
22 Sep 2020

View more

Sector
Healthcare
Contract Type
Permanent
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At some point in your career, you might be willing to take more responsibilities, to have more autonomy regarding your role in order to develop your skills.

This is a chance for you to take, being part of the Global team you will be assigned a portfolio of Biologic products. depending on the Global strategy you will define, implement, and lead the CMC strategy for your portfolio.

This is where you will have the opportunity to develop your knowledge while still working on interesting products.

Your task:
  • You will be responsible for the regulatory support for the CMC matters for the biologic products during their life cycle management.
  • Therefore you will define, implement, and lead the regulatory strategy for the CMC submission.
  • Provide the information needed by the Health Authorities and bring responses to their questions.


Your experience:
  • 5/7 Years of experience in the Pharmaceutical Industry working mainly on the Module 3.
  • Having experience on a manufacturing site OR in Quality assurance is a strong asset.
  • Capacity to exchange with the health authority regarding the CMC matters with the pre & post-approval product
  • Experience with Biologics products.


Do you think you would be a good fit? Do you want to know more about the role? Do not hesitate to contact me.

Contact:

Feel free to reach me even if the position is not exactly what you are looking for. Please share it with your network or any person you think you might be interested in.

You can send me your CV, Resume with your contact through the link.
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