Regulatory Affairs Manager - CMC 12 month contract

Remote Working
Competitive rate
18 Jul 2019
17 Aug 2019
Regulatory Affairs, CMC
Full Time
Contract Type
Experience Level

The opportunity to work with a leading Life Sciences Consultancy who works with 19 out of 25 of the top Life Sciences companies has become available! My Client is urgently seeking an experienced CMC Regulatory Affairs professional to work with them on a remote basis 5 days per week!

This role requires experienced professionals with strong CMC experience to work with them on Biologic products including monoclonal antibodies and insulin products.

Responsibilities include:

  • CMC clinical (CTA/IND) and commercial filings through involvement at all steps of dossier authoring, review, approval:

-New applications for biological products including for monoclonal antibodies, insulin products

-License Maintenance of biological products: post authorization Changes, recurrent filings: annual reports, renewals

-Post-Marketing Commitments (PMCs) and Follow-up Measures (FUM)

  • Develop global Regulatory CMC strategies for client’s biologics products to facilitate overall program goals
  • Provide regulatory CMC expertise on cross-functional project teams working with suppliers and contract manufacturers
  • Actively manage complex CMC regulatory submissions and ensuring quality and timelines are met for all pre and post approval biologics submissions

Suitable candidates will have:

  • A graduate degree in Life Sciences
  • Extensive experience in pre and post approval biologics CMC, including for monoclonal antibodies, insulin products regulatory filings
  • Biosimilar experience would be an advantage
  • Significant knowledge on Biologics regulatory requirements
  • Significant knowledge of ICH guidelines and BLA submission requirements of various markets such as USFDA, EMA etc

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  

I look forward to hearing from you soon!

Jasmine Smith

Contract Consultant ~ Regulatory Affairs

+ 44 (0)1293 77 66 44



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