My client is a global biopharma company. They are seeking a Regulatory Affairs Manager (CMC) to join our Regulatory Affairs Team based in Cambridge on a 12 month contract.
Hybrid working
Key Responsibilities
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 Knowledge, Experience and Skills
Must have significant experience in regulatory affairs and an extensive knowledge...