Cambridge - Regulatory Affairs CMC Manager contract

Your new company

This pharmaceutical company is looking for an experienced Regulatory Affairs CMC professional to join an established team on a contracting basis. This is a 12-month contract job with scope for extension, hybrid working is available, and there will be a need for an onsite presence in Cambridge.

Your new role

As Regulatory Affairs CMC Manager, you will be responsible for coordinating the preparation of high-quality CMC documents to support regulatory submissions in International regions (Asia, Latin America, Middle East, Eastern Europe and Africa).You will work with pharmaceutical development, manufacturing, QA and external partners to deliver the CMC components for marketing applications, variations and renewals as well as coordinating the preparation of responses to CMC questions from regulatory authorities.

In order to be considered for this contract job as Regulatory Affairs Manager CMC, you must have significant Regulatory CMC experience and be capable of preparing and finalising CMC regulatory dossiers, as well as, managing the ongoing maintenance of existing product licenses.

Flexible working options available.

For more information on this or any other Regulatory Affairs contract jobs, please apply to this advert.