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The consultant will handle Hungarian legal content, including translation, review, validation, and quality assurance. They are responsible for ensuring terminology accuracy and compliance with domain standards while coordinating with project stakeholders.
The role involves developing and executing a global regulatory strategy while overseeing corporate governance frameworks across all legal entities. The incumbent will lead a team to ensure compliance with international laws, manage regulatory filings, and provide strategic guidance to senior leadership.
Provide legal support to business stakeholders across EMEA, focusing on negotiating commercial contracts and managing disputes. Lead compliance efforts, corporate governance, and provide legal counsel for M&A and joint venture activities.
Draft, review, and negotiate agreements with study sites while ensuring compliance with budgetary and contractual parameters. Coordinate with internal functional teams to align site startup activities and achieve target cycle times for site activation.
Lead the annual Long-Term Supplier Declaration process for medical sites in Switzerland and coordinate export license administration across EMEA. Manage complex compliance activities, including origin determination and risk assessments for imports and exports.
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Act as the primary point of contact for clients to coordinate the delivery of legal entity management services. Manage legal compliance requirements, annual filings, and maintain accurate client documentation through a network of local service partners.
Develop and execute submission strategies for post-approval CMC activities, including variations and renewals for vaccines and biologicals. Coordinate with cross-functional departments to review study reports and ensure compliance with global regulatory requirements.
Develop and execute submission strategies for post-approval CMC activities, including variations and renewals for biologicals and vaccines. Coordinate with cross-functional departments to review study reports and ensure compliance with global regulatory requirements.
Responsible for the timely delivery of site activation readiness and the preparation of submission dossiers for Competent Authorities and Ethics Committees. The role involves coordinating with CRAs and project teams to manage essential documents and ensure compliance with local and international regulations.
Responsible for the timely delivery of site activation readiness and the preparation of submission dossiers for Competent Authorities and Ethics Committees. The role involves coordinating with CRAs and project teams to manage essential documents and ensure compliance with local and international regulations.
The Corporate Counsel will manage commercial contracting, corporate governance, and litigation matters across the EMEA region. They will provide business-focused legal advice to cross-functional teams including sales, finance, and HR.
The Corporate Counsel will manage commercial contracting, corporate governance, and litigation matters across the EMEA region. They will provide business-focused legal advice to cross-functional teams including sales, finance, and HR.
The role supports the global framework for identifying and managing third-party risks and fraud detection initiatives. It involves collaborating across various departments to embed compliance controls and monitoring transactions for unethical sourcing or conflicts of interest.
The Regulatory Affairs Manager will lead the preparation of global clinical trial submissions and provide strategic regulatory guidance to internal and external clients. They are responsible for overseeing multiple projects, managing budgets, and ensuring high-quality regulatory performance across the clinical development lifecycle.
The Senior Consultant acts as the principal labeling strategist within Global Regulatory Affairs, driving the development and maintenance of key labeling documents like the CCDS, USPI, and EU SmPC for assigned products. This role ensures optimal alignment of company position, labeling requirements, and commercial opportunities while providing strategic input from a labeling perspective to the GRA Therapeutic Area Team.
This role involves continuously monitoring, analyzing, and translating local, regional, and global regulatory developments into actionable insights for regulatory teams and stakeholders. Key duties include conducting impact assessments on regulatory changes and actively engaging in industry forums to inform forward-looking regulatory strategies.
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