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Specialist/Snr Specialist Study Start Up and Regulatory Affairs

Added

7 hours ago

Location

🌍 Europe

Type

Full time

Salary

Salary not provided

Related skills

regulatory affairs regulatory submissions ich-gcp translations study start-up

Why Job Hunt? Let AI Run Your Business

Describe it — AI builds, launches & grows it.

📋 Description

Lead and coordinate activities for site initiation readiness
Provide regulatory subject matter expertise and liaison with teams/clients
Deliver study start-up and regulatory milestones within scope
Make independent regulatory process decisions
Handle medium-complexity regulatory environments multi-country
Lead start-up docs, submissions, translations for accuracy/compliance

🎯 Requirements

Graduate degree in Chemistry or Life Sciences or Nursing
Minimum 4 years in pharma, CRO, or regulatory body
Good knowledge of ICH GCP and national regs
Understanding country SSU/regulatory requirements

🎁 Benefits

Quality-focused culture with integrity and trust
Agility and responsiveness to timelines
Collaborative, international team environment
Commitment to work-life balance

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