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The Regulatory Submission Manager leads operational submission execution for clinical trial applications and acts as the regional regulatory representative within study teams. They are responsible for driving global submission strategies, managing documentation, and ensuring compliance with industry and agency guidelines.
Provide expert legal analysis on the EU AI Act, GDPR, and data governance to support AI model training and compliance. Identify legal inaccuracies in AI-generated responses and develop structured legal reasoning and evaluation criteria.
Develop comprehensive regulatory strategies for performance evaluation studies and lead interactions with health authorities and notified bodies. Manage regulatory activities throughout the IVD clinical development lifecycle and ensure timely, compliant submissions.
The consultant will lead regulatory strategy for medical devices and combination products, managing interactions with health authorities and notified bodies. They will also oversee technical documentation, ensure compliance throughout the clinical development lifecycle, and collaborate with cross-functional teams on submissions.
The consultant will prepare CMC sections for regulatory submissions and manage lifecycle activities for biologics products. They will also provide technical consulting, coordinate project timelines, and develop regulatory strategies for combination products.
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The Senior Director is responsible for driving business development, managing key client relationships, and overseeing strategic consulting engagements. They lead cross-functional teams to deliver expert guidance on RWE, HEOR, and market access while fostering internal innovation.
Legal fellows will conduct research on complex legal questions, draft licensing agreements, and develop internal and external policies. They will work under the supervision of an attorney to support the Foundation's legal department on various projects.
The consultant will manage controlled document governance and ensure inspection readiness across global GxP operations. They will also oversee quality systems, including deviations and CAPAs, while driving continuous improvement in compliance processes.
The Regulatory Affairs Consultant manages clinical trial application (CTA) submissions and associated documentation while partnering with study teams. They also lead meetings to advocate for deliverable timelines and ensure high-quality, compliant global submission delivery.
The Senior Regulatory Affairs Consultant manages regulatory activities and deliverables associated with Clinical Trial Applications (CTA) submissions. They also lead study teams and collaborate with global partners to ensure high-quality, compliant submission packages are delivered on time.
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.
The Legal Advisor will draft, review, and negotiate a wide range of commercial and software agreements while ensuring corporate compliance across multiple jurisdictions. They will also support business development through RFP participation and conduct legal research to provide opinions on business needs.
Lead the global data privacy strategy and framework while providing strategic leadership on compliance and risk management. Advise senior leadership on data privacy obligations and drive a privacy-by-design culture across the organization.
The Senior Security Compliance Specialist will lead annual PCI assessments and manage the end-to-end compliance process with internal and external stakeholders. They will also ensure ongoing validation of the PCI environment scope and develop detailed analysis to support organizational compliance efforts.
The Legal Counsel will provide comprehensive legal support for commercial, operational, and regulatory matters while maintaining data protection standards. Additionally, the role involves building a scalable legal function through process automation, contract lifecycle management, and interdepartmental coordination.
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.
Support the legal department of a joint-stock company with corporate governance and employment documentation. Monitor legal changes and assist in drafting internal regulations and legal opinions for the Group.
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The role involves managing regulatory activities and client projects to secure and maintain marketing authorizations for human and veterinary medicinal products in Poland. Key duties include communicating with health authorities, providing regulatory consultancy, and overseeing lifecycle management 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.
Provide end-to-end legal support across group entities, focusing on corporate maintenance, commercial contracts, and regulatory compliance in the UK, EU, and Cyprus. The role involves managing M&A transactions, IP matters, and leveraging AI tools to optimize legal operations.
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.
Responsible for ensuring compliance with dangerous goods and transportation regulations across European sites, specifically implementing the EU-PIC regulation. The role involves managing export notifications, auditing safety data sheets, and developing training programs for hazardous materials management.
The Regulatory Affairs Manager - Poland is responsible for managing regulatory activities and client projects focused on Polish market requirements. This includes maintaining marketing authorizations, leading submission activities, and communicating with health authorities.
Responsible for corporate governance, regulatory licensing (EMI/VASP), and legal support for payment infrastructure in the digital assets sector. The role involves managing supervisory relations, drafting commercial contracts, and overseeing AML/CFT legal frameworks.
Provide strategic legal guidance on intellectual property, technology product development, and data licensing for a global organization. Partner with cross-functional teams to ensure products and services comply with IP, data, and regulatory requirements from conception to launch.
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Facilitate site budget and contract negotiations to ensure prompt execution and adherence to study timelines. Manage clinical trial agreements and collaborate with internal teams and CROs to improve SB&C metrics.
The Legal Specialist is responsible for drafting and reviewing legal agreements and maintaining corporate documentation and ownership structures. They also ensure regulatory compliance across multiple jurisdictions and communicate with external service providers.
Manage global regulatory affairs support services, including clinical trial applications and compliance reporting across North America, LATAM, and the EU. Provide expert guidance to stakeholders and develop corporate regulatory strategies to meet evolving industry standards.
Perform high-level analysis of complex legal and regulatory filings and provide expert knowledge-based answers. Validate the professional accuracy of B2B research outputs to help train AI models.
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