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, (Asia, Latin America, Middle East, Eastern Europe and Africa). 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 Must have excellent organizational skills and an ability to work on several projects with tight timelines
We hope to hear from you soon.