Compliance

• Own audit readiness and tax regulatory compliance across all European entities
• Design the region's audit and compliance approach and establish consistent processes
• Lead end-to-end local statutory and global group audits across 23 countries
• Plan audits, coordinate PBC lists, and drive on-time sign-off
• Act as primary regional contact for external auditors and own resolution of open items
• Align local statutory filings with Global/Group reporting timelines under IFRS, US GAAP, and local GAAP
• Define pre-audit preparation requirements with local teams
• Oversee VAT, Withholding Tax, Corporate Income Tax, statistical, and national bank reporting
• Standardize supporting data submissions to the central Tax team and ensure audit readiness
• Manage tax notices and audits, coordinate evidence gathering, and support timely responses
• Oversee annual corporate filings and coordinate with Legal on board meeting minutes and regulatory requirements
• Identify recurring audit adjustments and tax queries and implement structural fixes
• Strengthen internal controls across the region
• Champion AI, automation, and dashboarding tools to reduce manual work and improve reporting consistency
• Collaborate with Tax, Transfer Pricing, Legal, hub-entity finance teams, local reporting teams, and external accountants

Audit & Compliance Manager

• Review study budgets and costing related to contract negotiation
• Participate in business development activities
• Prepare regulatory sections of proposals and feasibility reports
• Attend bid defense meetings
• Coordinate and manage regulatory and ethics committee submissions throughout EMEA, Asia Pacific and Latin America
• Maintain approvals and accurately compile, manage, and track submissions
• Provide expert regulatory advice and contribute to regulatory project work
• Communicate submission status with Sponsors, Project Managers, CRAs, and Medical & Scientific Affairs staff
• Contribute to technical documentation such as IMPDs and IBs
• Review documentation and make recommendations to ensure compliance with ICH GCP and country-specific requirements
• Provide training, coaching, and mentoring to junior staff
• May line manage junior staff

Manager, Regulatory Affairs – EMEA

• Provide regulatory strategy and development guidance throughout clinical trials
• Guide regulatory agency meetings, orphan designations, paediatric planning, and accelerated procedures
• Coordinate and prepare regulatory documents for submission to Regulatory Authorities and/or Ethics Committees
• Compile, coordinate, and review CTA/IND applications, annual reports, routine amendments, scientific advice and regulatory authority meeting materials, orphan designations, paediatric planning, and marketing applications
• Develop and/or review submission documents to ensure compliance with regulatory standards
• Represent Global Regulatory Affairs at project team and business development meetings with internal and external customers
• Work within project teams and lead regional or global projects when necessary
• Oversee and coordinate Regulatory Affairs Specialists to achieve submission targets
• Maintain project plans, project trackers, and regulatory intelligence tools; keep Regulatory Leadership updated
• Assist in developing Regulatory Affairs Specialists and other operational staff
• Contribute to regulatory strategy and timeline development for new study opportunities
• Assist in establishing company standards for high-quality submitted information
• Participate in corporate quality initiatives across Clinical Solutions business units
• Maintain and expand knowledge of laws, regulations, and guidelines governing drug development and approval
• Provide ICH GCP guidance, advice, and training to internal and external clients

Regulatory Manager – Senior Regulatory Manager

• Provide regulatory strategy and development guidance for clinical trials, regulatory agency meetings, orphan designations, paediatric planning, and accelerated procedures
• Coordinate and prepare regulatory documents for submission to Regulatory Authorities and Ethics Committees
• Provide regulatory guidance throughout the clinical development life cycle
• Compile, coordinate, and review CTA/IND applications, annual reports, routine amendments, scientific advice and regulatory authority meeting materials, orphan designations, paediatric planning, and marketing applications
• Provide strategic regulatory input as required
• Develop and review submission documents for compliance with regulatory standards
• Represent Global Regulatory Affairs at project team meetings with external and internal customers
• Work within project teams and lead regional or global projects when necessary
• Oversee and coordinate Regulatory Affairs Specialists to achieve submission targets
• Maintain project plans, trackers, and regulatory intelligence tools; update Regulatory Leadership
• Assist in developing Regulatory Affairs Specialists and other operational staff
• Contribute to regulatory strategy and timeline development for new study opportunities
• Help establish company standards for high-quality submitted information
• Participate in corporate quality initiatives across Clinical Solutions business units
• Maintain current knowledge of laws, regulations, and guidelines governing drug development and approval
• Provide ICH GCP guidance, advice, and training to internal and external clients
• Represent Global Regulatory Affairs at business development meetings