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Specialist/Snr Specialist Study Start Up and Regulatory Affairs

Added

1 day ago

Location

🌍 Europe

Type

Full time

Salary

Salary not provided

Related skills

documentation regulatory affairs ich-gcp regulatory strategy 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 timely delivery milestones
Serve as liaison between internal teams, clients and external stakeholders
Handle multi-country regulatory environments where applicable
Prepare, review and QC regulatory documentation and translations
Develop SSU regulatory strategy and plans

🎯 Requirements

Graduate degree in Chemistry or Life Sciences, Nursing or equivalent
Minimum 4 years in pharma/CRO or regulatory bodies
Strong knowledge of ICH-GCP and national regulations
Understanding of SSU/regulatory delivery across Europe and/or Americas

🎁 Benefits

Join a collaborative, international team
Focus on rare disease and oncology trials
Culture emphasizes quality, integrity and agility
Supportive environment with work-life balance

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