** New Contract - Regulatory Affairs Manager, CMC - Global Biotech - Hybrid, Cambridgeshire **
Thrilled to be working on this brand new long term contract vacancy with my Global Biotech client based in the UK.
We are searching for a Regulatory Affairs Manager, CMC to join their team for a minimum period of 12 months.
Specific Job Requirements
We have a 12 month contract opportunity for a Manager Regulatory Affairs CMC to join our Regulatory Affairs Team based in Cambridge.
Core Duties include
Knowledge, Experience and Skills
- 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
- 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 a number of projects with tight timelines.
This is a hybrid role in which you will be required to work office based for 3 days per week.
If you are suitable, available and interested in this post, please do not hesitate to get in touch.
020 3019 3985