Study Start Up and Regulatory Affairs Specialist

• Lead and coordinate activities required to achieve site initiation readiness
• Provide subject matter expertise on study start-up and regulatory affairs
• Ensure regulatory compliance and 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
• Handle medium-complexity regulatory environments, including multi-country requirements where applicable
• Lead study start-up and regulatory activities for assigned countries or projects in line with timelines, quality standards, and regulatory requirements
• 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
• Review labels, patient information sheets, diary cards, insurance documents, and other relevant documentation
• Provide regulatory and study start-up strategic input to internal and external customers
• Develop regulatory strategies, 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
• 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 for study start-up and regulatory delivery in multiple countries within Europe and/or the Americas
• Ability to lead study start-up and regulatory activities for countries or projects of medium complexity
• Ability to prepare, review, and quality-control regulatory and study start-up documentation
• Ability to draft, negotiate, finalize, and execute clinical site agreements, ancillary agreements, and amendments
• Knowledge of regulatory and clinical documentation, including labels, patient information sheets, diary cards, and insurance documentation
• Ability to contribute to complex technical, scientific, and legal documentation
• Ability to arrange and/or review translations of essential documents
• Ability to develop regulatory strategies, study start-up plans, joint operating procedures, and core documents
• Ability to identify and escalate project risks and support corrective/preventive actions

• Remote work option
• Work-life balance
• Collaborative international team
• Career growth opportunities
• Ownership and autonomy early in career
• Opportunity to work on meaningful clinical research supporting safe and effective pharmaceutical treatments
• Collaborative and supportive work environment