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Senior Manager, Regulatory CMC

Gleeson Recruitment Group
Hatfield
1 week ago
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Job title: Senior Manager, Regulatory CMC



A pharmaceutical business in London are seeking a Senior Manager, Regulatory CMC to join their team. The role will be responsible for providing CMC regulatory support for established products including growth market submissions and any post-approval activities relevant.



Responsibilities:



  • Collaborate with IPT and CMC teams supporting development projects towards license submission and approval.
  • Preparation of regulatory roadmaps and gap analysis for the development of biosimilars up to approval.
  • Provide CMC expertise cross functionally.
  • Report on regulatory progress and issues for new products or LCM activities at all project team and Project Review Meetings, and to Senior Management as required.


Requirements:



  • Experience in CMC Regulatory within the pharmaceutical or biotechnology industry
  • Experience with Small Molecules is a must have and any experience in Biologics would be a bonus.
  • Experience interacting with EU regulatory authorities – Scientific advice meetings/ Pre-submission meetings.
  • Degree in Life Sciences would be beneficial



Salary and benefits:


A highly competitive salary and wider benefits scheme is on offer


To apply for this position or hear further details then please contact Freddie Hill via

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