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
• Handle medium-complexity regulatory environments, including multi-country requirements where applicable
• 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 other documentation for ICH-GCP and country-specific compliance
• Contribute to preparation and/or review of complex technical, scientific, and legal documentation
• Arrange and/or review translations of essential documents
• Provide regulatory and study start-up strategic input to internal and external customers
• Develop regulatory strategy, study start-up plans, joint operating procedures, and core documents
• Identify and escalate risks that may jeopardize project deliverables and support corrective/preventive actions
• Perform other work-related duties as assigned

• Graduate degree in Chemistry or Life Sciences, Nursing, or equivalent combination of education and experience
• Minimum 2 years 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
• Ability to lead study start-up and regulatory activities for assigned countries or projects of medium complexity
• Knowledge of regulatory and study start-up documentation, submissions, essential documents, and translations
• Knowledge of clinical site agreements, ancillary agreements, and amendments
• Knowledge of labels, patient information sheets, diary cards, insurance, and related documentation
• Ability to contribute to complex technical, scientific, and legal documentation
• Regulatory and study start-up strategic planning knowledge
• Ability to identify and escalate project risks and support corrective/preventive actions
• Ability to make independent decisions within assigned scope regarding regulatory processes and documentation approaches

• Remote work option
• Work-life balance
• Collaborative, international team environment
• Career growth opportunities
• Opportunity to take ownership early
• Supportive workplace culture
• Passionate and collaborative team of experts
• Values-driven work environment
• Opportunity to help bring safe and effective pharmaceutical treatments to patients