Compliance

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

Audit & Compliance Manager

• Build and lead team.blue’s central Compliance function within group legal
• Lead and develop Privacy Counsels, AI Counsels, and the general compliance risk-monitoring and assurance function
• Act as a first-line advisory function embedded in group legal and work alongside legal and business teams
• Drive practical implementation of regulatory requirements into business lines
• Apply a risk-based approach to prioritise compliance efforts across brands and jurisdictions
• Own the group compliance agenda for GDPR, the AI Act, the Data Act, DORA and NIS2
• Centrally coordinate the group’s Digital Services Act standard
• Set group standards, policies and playbooks and deploy them through self-serve templates and Legal Hub automation
• Anticipate incoming EU digital regulation and assess operational impact across the portfolio
• Own or coordinate sanctions, AML, conflicts of interest, third-party risk management, fraud, consumer protection and business integrity topics
• Safeguard independent judgement and provide independent oversight on escalation
• Own continuous compliance risk monitoring, assurance, regulatory watch and register-driven action
• Steer the function using KPIs such as maturity and awareness, self-serve adoption, response time and residual risk
• Partner with divisional General Counsels to embed compliance across business lines
• Foster compliance culture and enable local counsels and non-legal teams to self-serve
• Advise senior leadership and divisional GCs on compliance risk and regulatory exposure
• Work with the Sustainability Director on the digital-trust agenda and responsible-technology commitments

Head of Compliance

• Work with Regulatory Coordinators to create documents for parallel import licensing
• Oversee packaging material creation and maintenance
• Create mock-ups using printers, plotters, label printers, Braille printers and cameras
• Maintain packaging material data and files
• Create photo documentation of repackaged medicine samples prepared for licensing
• Administer tasks in the department’s task management tool
• Work with Photoshop, Adobe Illustrator and Office 365
• Help create efficient repackaging methods for different production sites
• Print and assemble packaging materials for medicines in cooperation with colleagues acquiring EU marketing authorization for parallel-imported medicines

Regulatory Coordinator – Design

• 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/or 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
• Develop and review submission documents to ensure compliance with regulatory standards
• Represent Global Regulatory Affairs at internal and external project team meetings
• 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
• Represent Global Regulatory Affairs at business development meetings

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/or Ethics Committees
• Provide regulatory guidance throughout the clinical development life cycle
• Compile, coordinate, and review CTA/IND applications, annual reports, routine amendments, scientific advice/regulatory authority meetings, orphan designations, paediatric planning, and marketing applications
• Develop and/or review submission documents for regulatory compliance
• Represent Global Regulatory Affairs at internal and external project team meetings
• 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 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

Compliance jobs in Hungary

Audit & Compliance Manager

Head of Compliance

Regulatory Coordinator – Design

Regulatory Manager – Senior Regulatory Manager

Regulatory Manager / Senior Regulatory Manager