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The Regulatory Manager provides strategic regulatory guidance throughout the clinical development life cycle and coordinates submissions to regulatory authorities. They also lead project teams, oversee regulatory specialists, and ensure compliance with global regulations and quality standards.
The Regulatory Manager provides strategic regulatory guidance throughout the clinical development life cycle and coordinates submissions to regulatory authorities. They also lead project teams, oversee regulatory specialists, and ensure compliance with global regulations and quality standards.
The manager will oversee regulatory and ethics committee submissions across EMEA, Asia Pacific, and Latin America while ensuring compliance with global standards. They will also support business development activities, mentor junior staff, and provide strategic regulatory guidance for clinical trials.
Develop and execute post-approval regulatory submission strategies for CMC activities related to biological and vaccine products. Coordinate cross-departmental efforts to ensure compliance and manage regulatory documentation within information management systems.
The Regulatory Affairs Consultant will manage post-approval CMC activities, including developing submission strategies and assessing change controls for biological and plasma products. They will coordinate with cross-functional departments to ensure regulatory compliance and maintain documentation within information management systems.
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The Legal Counsel will lead and manage sales and procurement-related legal matters for the Amcor Rigids EMEA business group. This includes drafting and negotiating complex commercial contracts, managing litigation, and providing strategic legal guidance to business stakeholders.
The role involves performing specialized legal data annotation and evaluation for contract management platforms. Responsibilities include analyzing clauses and obligations within complex business agreements while collaborating on multi-use-case workflows.
You will own the day-to-day legal queue, handling high-volume commercial contracts, data protection requests, and employment documentation. Additionally, you will build and maintain legal templates, playbooks, and FAQs to help the legal team scale effectively.
The Regulatory Reporting Officer will own the design and control of reporting pipelines to ensure transaction and position reports are accurate, complete, and timely. They will also manage validation errors, support audits, and act as a point of contact for delegated reporting clients.
You will be responsible for the preparation and submission of regulatory documents in compliance with EU CTR and other applicable guidelines. Additionally, you will provide leadership for clinical trial start-up activities and serve as the primary point of contact for sponsors and project teams.
The Data Privacy Manager will support the operation and continuous improvement of the global privacy program, including conducting PIAs and DPIAs. They will also manage data subject rights requests, review privacy-related contracts, and monitor regulatory developments like GDPR and the AI Act.
The specialist will drive global regulatory strategy by providing intelligence, managing advocacy initiatives, and supporting innovation programs. They will act as a liaison between regulatory, R&D, and commercial teams to manage risks and ensure compliance across the global product portfolio.
The Principal Security Compliance Analyst will design and maintain a comprehensive ISO governance and certification program at an enterprise scale. This role involves leading audit activities, driving the expansion of certifications like TISAX and C5, and embedding compliance controls into business processes.
The Senior Director will partner with the EVP of Global Quality to develop and execute global quality and compliance strategies across clinical research services. They will lead quality transformation initiatives, oversee regulatory inspections, and manage a team of quality leads to ensure operational excellence and inspection readiness.
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.
Lead comprehensive KYC/KYB due diligence for counterparties and manage onboarding processes with payment service providers and financial institutions. Develop and optimize compliance frameworks, AML policies, and counterparty screening tools to ensure regulatory adherence.
Lead comprehensive KYC/KYB due diligence and manage onboarding processes with payment service providers and external partners. Develop and optimize KYC processes, AML policies, and counterparty screening tools to ensure regulatory compliance.
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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.
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.
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 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.
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.
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.
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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.
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