Regulatory Affairs CMC Manager
A fantastic vacancy has become available for a Regulatory Affairs CMC Manager in Cambridge. This pharmaceutical regulatory affairs job is an excellent opportunity to work for a global leader in the life sciences industry.
- Co-ordinate the preparation of high-quality CMC documents to support regulatory submissions in International regions.
- Work with pharmaceutical development, manufacturing, QA and external partners to deliver the CMC components for marketing applications, variations and renewals
- Co-ordinate the preparation of responses to CMC questions from regulatory authorities
- Maintain an up to date awareness of CMC regulatory requirements for applicable territories and communicate key intelligence to the organization in a timely manner
Skills and Requirements
- Must have significant experience in regulatory affairs and an extensive knowledge of regulatory requirements, including ICH requirements and regional requirements
- Must be capable of the preparation and finalization of CMC regulatory dossiers and managing the ongoing maintenance of existing product licenses
- Well versed and competent with regulatory documentation and submission management systems
- Excellent verbal, written and interpersonal communication skills are required
In case you have difficulty in applying or if you have any questions, please contact Peter Duvall on 44 203 0789 542 or upload your CV on our website - www.proclinical.com/send-cv
A full job description is available on request.