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Specialist/Snr Specialist Study Start Up and Regulatory Affairs

Added

1 hour ago

Location

🌍 Europe

Type

Full time

Salary

Salary not provided

Related skills

documentation regulatory affairs ssu ich-gcp regulatory compliance

Why Job Hunt? Let AI Run Your Business

Describe it — AI builds, launches & grows it.

📋 Description

Lead and coordinate study start up and regulatory activities
Ensure regulatory compliance and liaise with internal/external stakeholders
Deliver assigned start-up and regulatory milestones within scope
Make independent regulatory process decisions
Handle medium complexity regulatory environments
Lead SSU activities for countries/projects with timelines and quality goals

🎯 Requirements

Graduate degree in Chemistry or Life Sciences, Nursing or equivalent
Minimum 4 years in pharma/CRO or regulatory body
Solid knowledge of ICH GCP and national regs
Understanding of country-specific SSU/regulatory delivery in Europe/Americas

🎁 Benefits

Quality is a core value
Integrity and trust in actions
Drive and passion for outcomes
Agility and responsiveness to patients
Belonging and inclusivity
Collaborative partnerships and teamwork

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