Job Description
* Regulatory Affairs Consultant – EU Strategy
* UK-based, Hybrid – 3x a week on-site in Surrey, UK.
* 10-to-12-month contract – Inside IR35
* PAYE rate up to £33.78 p/h OR Umbrella rate up to £37.86 p/h
JOB SUMMARY
* Represent a particular region for regulatory sciences (US, EU or EM)
* Provide regional strategic expertise as a member of the Global Regulatory Strategic Team (GRST).
* Lead and implement regional regulatory strategies in agreement with key stakeholders for assigned projects/products and in line with the commercial goals.
* Accountable for timely submissions and approvals with commercially attractive labeling in the designated region.
* Accountable for ensuring optimal regulatory interactions with Health Authorities, in relation to the assigned project(s) within the designated region.
* Role can be combined with other Regulatory Role(s) (i.e., Global Regulatory Lead).
JOB RESPONSIBILITIES
1. Accountable for ensuring regional (US, EU or EM) contribution to Global Regulatory Strategies and implementation plans (including core labels, risk registers) for assigned projects.
2. Ensures regulatory contributions achieve the objectives in the strategy, achieve agreed standards, maximizing overall project delivery time and probability of success and facilitating post-fi...