Country Approval Specailist Fsp - Italy, France & Spain
Thermo Fisher Scientific UK
Italy, Country
Local regulatory submissions preparation
Country-specific regulatory strategy advice
Clinical trial site start-up coordination
You will play a key role in managing and coordinating local regulatory submissions across Italy, France, and Spain in alignment with global strategies
Job Summary
You will play a key role in managing and coordinating local regulatory submissions across Italy, France, and Spain in alignment with global strategies.
The position involves providing local regulatory strategy advice to internal clients and acting as the key contact for ethical or regulatory activities at the country level.
Candidates must ensure that site start-up activities are aligned with submission processes to meet critical path timelines for study activation.
Matching Summary
You will play a key role in managing and coordinating local regulatory submissions across Italy, France, and Spain in alignment with global strategies.
Skills & Requirements
Must-have
local regulatory submissions preparation
country-specific regulatory strategy advice
clinical trial site start-up coordination
patient information sheet development
regulatory compliance review packages
Nice-to-have
strong negotiation skills with sites
ability to work independently under direction
basic medical terminology knowledge
experience with gene therapy approvals
effective oral and written communication
Key Requirements
Bachelor's degree or equivalent qualification
2+ years of relevant experience
Knowledge of regional/national regulatory guidelines