Study Start Up and Regulatory Affairs Specialist

📋 Description

• Leads and coordinates all activities related to achieving site initiation readiness
• Accountable for delivery of assigned study start-up and regulatory milestones
• Makes independent decisions within assigned scope regarding regulatory processes and documentation
• Handles medium-complexity regulatory environments, including multi-country requirements
• Leads study start-up and regulatory activities for assigned countries or projects
• Leads preparation, review, and quality control of regulatory and study start-up documentation

🎯 Requirements

• Graduate degree in Chemistry, Life Sciences, Nursing, or equivalent combination of education and
• Previous experience within pharmaceutical or CRO industry or Regulatory body
• Good knowledge of ICH GCP and national regulations for territories of competency
• Good understanding of specific country requirements pertaining to SSU/Regulatory delivery in

🎁 Benefits

• Work with purpose in a specialist CRO focused on rare disease and oncology
• Collaborative, international team
• Flexibility and commitment to work-life balance
• Opportunity to take ownership early
• Make a difference by helping to bring safe and effective pharmaceutical treatment to patients
• Work alongside passionate experts in clinical research, pharmacovigilance, and quality consulting