Senior Manager, Regulatory Affairs CMC

1 day ago

Cambridge, Cambridgeshire, United Kingdom Gleeson Recruitment Group Full time
Job Title: Senior Manager, Regulatory Affairs CMC

We are seeking a highly skilled Senior Manager, Regulatory Affairs CMC to join our team at Gleeson Recruitment Group. As a key member of our Regulatory Affairs team, you will be responsible for developing and executing global regulatory CMC strategies and submissions.

Key Responsibilities:

  • Develop and execute global regulatory CMC strategies and submissions, including CMC dossiers to support clinical trial applications and marketing applications.
  • Collaborate with internal Technical Operations colleagues and external organizations to develop submission content plans and timelines and support the timely execution of regulatory submissions that require CMC content, responses to questions, audits and inspections.
  • Manage the preparation, drafting, review, risk analysis and mitigation planning of CMC submissions e.g. Module 3 IND, IMPD, amendments and annual reports.

Requirements:

  • Experience in CMC Regulatory Affairs within the pharmaceutical or biotechnology industry.
  • Experience and knowledge in preparation of CMC sections of INDs, CTAs, and marketing applications is required.
  • Working knowledge of FDA, EMA, ICH and cGMP CMC regulatory guidance and regulations.
  • Experience working with recombinant proteins is highly desirable.
  • Experience interactions with health authorities such as scientific advice or agency meetings, including with FDA, is desirable.
  • Minimum of first degree in life sciences (or equivalent); advanced degree (e.g. PhD or Masters) preferred.

What We Offer:

A highly competitive salary and wider benefits scheme is on offer to the successful candidate. If you are a motivated and experienced Senior Manager, Regulatory Affairs CMC looking for a new challenge, please contact Freddie Hill via Freddie.hill@pharma-partners.co.uk to discuss further.

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