Study Start Up and Regulatory Affairs Specialist

• Lead and coordinate activities required to achieve site initiation readiness
• Provide subject matter expertise and ensure regulatory compliance
• Liaise with internal teams, clients, and external stakeholders
• Deliver assigned study start-up and regulatory milestones within defined scope
• Make independent decisions regarding regulatory processes and documentation approaches
• Lead study start-up and regulatory activities for assigned countries or medium-complexity projects
• Prepare, review, and quality-control regulatory and study start-up documentation, including submissions, essential documents, and translations
• Draft, negotiate, finalize, and execute clinical site agreements, ancillary agreements, and amendments at country or regional level
• Review labels, patient information sheets, diary cards, insurance, and related documentation for ICH-GCP and country-specific compliance
• Contribute to complex technical, scientific, and legal documentation
• Arrange and/or review translations of essential documents
• Provide regulatory and study start-up strategic input
• Develop regulatory strategies, study start-up plans, joint operating procedures, and core documents
• Identify and escalate project risks and support corrective/preventive actions
• Perform other assigned work-related duties

• Graduate degree in Chemistry or Life Sciences, Nursing, or equivalent combination of education and experience
• Previous experience within the pharmaceutical or CRO industry or a regulatory body
• Good knowledge of ICH GCP and national regulations for territories of competency
• Good understanding of country-specific requirements pertaining to study start-up/regulatory delivery in multiple countries within Europe and/or the Americas
• Experience handling medium-complexity regulatory environments and multi-country requirements where applicable

• Remote work available
• Work-life balance
• Collaborative, international team environment
• Career growth opportunities
• Trusted ownership and flexibility
• Opportunity to contribute to meaningful work helping bring safe and effective pharmaceutical treatments to patients
• Passionate and collaborative team of experts in clinical research, pharmacovigilance, and quality consulting