An exciting contract opportunity has opened up with a globally renowned big pharmaceutical organisation in Cambridge, my client is seeking a Regulatory CMC Analyst. The core aim of the role is to produce and support the production and regulatory submission of Chemistry, Manufacturing and Control (CMC) documentation for commercial products at various stages of the product life-cycle. The successful candidate will work in partnership with relevant product and project teams providing regulatory and compliance advice, as appropriate.
Coordinate the assembly, including document requests and generation, of submission-ready components to support lifecycle submissions linked to license maintenance and post approval changes
Support the timely delivery and submission of post approval CMC documentation to marketing companies and health authorities
Review and approve regulatory CMC documents on behalf of Operations Regulatory
Work in partnership with stakeholders across Operations (including technical functions and manufacturing sites) and Global Regulatory Affairs
Advise on CMC regulatory and compliance focussed aspects of post-approval regulatory submissions
Support the progression and delivery of cross-functional documentation required by Global * Regulatory Affairs for inclusion in worldwide regulatory submissions
Maintenance of electronic systems to ensure the current regulatory submission and commitment status is accurately reflected, notifying relevant departments and groups of health authority approvals as they are received
Share knowledge and learnings gained from own projects with colleagues within and outside the department as appropriate
Required Skills & Knowledge & Experience
It is essential you are a graduate in a scientific discipline (e.g. chemistry, pharmacy or biological science) OR have at least 4 years experience in a Regulatory Affairs, Quality Assurance or Research and Development role linked to the Pharmaceutical industry.
Documentation management experience would be a significant advantage along with knowledge of systems such as Angel or Trackwise.
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