Regulatory CEP Submission Expert
Contract: 24 weeks
Apply NowWe are seeking a senior Regulatory Affairs Consultant with proven experience in Certificate of Suitability (CEP) submissions to the EDQM to support a pharmaceutical API development programme.
This is a part-time consultancy assignment with the potential to extend over several months. The client has staff who are generating the context, but require a senior consultant to advise and validate their work.
The Role
- Review and assess API development documentation, including characterization data, specifications, and regulatory strategy
- Advise on validation, stability, impurity, and compliance requirements relevant to CEP submissions
- Support preparation and review of CEP application sections for submission to the European Directorate for the Quality of Medicines (EDQM)
- Provide expert input on the restricted part of the CTD dossier
- Review outsourced study outputs (e.g. impurity and analytical testing data)
- Conduct a comprehensive pre-submission review of the full regulatory dossier
Requirements
- Extensive experience preparing and reviewing CEP applications for APIs
- Strong understanding of EDQM requirements and regulatory expectations
- Expertise in API development, process validation, stability studies, analytical validation, and impurity assessment
- Experience authoring and reviewing CTD documentation, including restricted sections
- Ability to provide strategic regulatory guidance and independent dossier review
- Part-time role
- Remote working
- Flexible duration, expected to be a medium- to long-term project
- Immediate or near-term start preferred
- Interested candidates should provide a summary of relevant CEP submission experience, availability, and consulting rates.
How to Apply
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