Regulatory Affairs Manager

Regulatory Affairs Manager

12 month contract

2 days per week in office either in Stockley Park or Cambridge

37.5 hours per week

£458.33 per day inside IR35

Duties include:
* 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 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.