Competitive salary; not specified; extensive benef...
Hybrid
Local regulatory submissions preparation
Ethical and regulatory submission activities
Site start-up activities coordination
PPD (Thermo Fisher) is seeking a Country Approval Specialist in the UK to manage and coordinate local regulatory submissions for clinical trials, ensuring alignment with global strategies. The ideal candidate will possess a relevant degree, strong communication skills, and a minimum of 2 years' experience in a similar role, along with knowledge of regulatory guidelines
Job Summary
The role involves preparing, reviewing, and coordinating local regulatory submissions in alignment with global strategies.
Candidates will serve as the key contact at the country level for ethical or regulatory submission-related activities.
PPD offers an award-winning learning and development programme along with a competitive salary and extensive benefits package.
Matching Summary
Match Score: 85
PPD (Thermo Fisher) is seeking a Country Approval Specialist in the UK to manage and coordinate local regulatory submissions for clinical trials, ensuring alignment with global strategies. The ideal candidate will possess a relevant degree, strong communication skills, and a minimum of 2 years' experience in a similar role, along with knowledge of regulatory guidelines.
Salary
Competitive salary; Not specified; Extensive benefits package including health and well-being focus
Skills & Requirements
Must-have
Local regulatory submissions preparation
Ethical and Regulatory submission activities
Site start-up activities coordination
Patient Information Sheet development
Trial status information maintenance
Nice-to-have
Strong negotiation skills with sites
Excellent interpersonal communication
Ability to work independently under direction
Collaborative team environment experience
Knowledge of gene therapy approvals
Key Requirements
Bachelor's degree or equivalent qualification
2+ years of relevant experience
Good English and German language skills
Basic medical terminology knowledge
Understanding of regional/national regulatory guidelines