Fsp Country Approval Specialist - Fully Client Dedicated Denmark And Sweden
PPD (Thermo Fisher) UK
Remote
Local regulatory submissions coordination
Regulatory strategy development
Communication with regulatory authorities
The Senior Country Approval Specialist manages the preparation, review and coordination of Country Submissions in line with global submission strategy
Job Summary
The Senior Country Approval Specialist manages the preparation, review and coordination of Country Submissions in line with global submission strategy.
You will serve as the primary contact for investigators and local regulatory authorities to ensure timely management of submissions and align site start-up activities with submission timelines.
When you join Thermo Fisher Scientific, you become part of a global team that values passion, innovation, and a commitment to scientific excellence.
Matching Summary
The Senior Country Approval Specialist manages the preparation, review and coordination of Country Submissions in line with global submission strategy.
Skills & Requirements
Must-have
local regulatory submissions coordination
regulatory strategy development
communication with regulatory authorities
knowledge of regional/national regulatory guidelines
preparation of compliance review packages
team collaboration and mentoring
Nice-to-have
negotiation skills
attention to detail
decision-making skills
organizational and planning skills
ability to work independently
excellent interpersonal skills
Key Requirements
Bachelor's degree or equivalent
5+ years relevant experience
Good English and Danish language skills
Knowledge of medical terminology
Experience with regulatory guidelines and EC regulations