Regulatory Affairs Manager

Regulatory Affairs Manager - CMC

37.5 hours per week

£458.33 per day - inside IR35

3 days per week in office in Cambridge, 2 days per week from home

12 month contract

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

Requirements

* Must have significant 5+ years of CMC Regulatory Affairs experience
* Must have a valid right to work in the UK and be willing to travel on site