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The Regulatory Labeling Manager will support labeling negotiations with health authorities and interpret safety data to inform labeling updates. They are responsible for preparing labeling components for eCTD submissions and utilizing structured content authoring tools.
The Senior Manager will lead cross-functional regulatory project management activities for global submissions, ensuring compliance with FDA, EMA, and ICH guidelines. They are responsible for managing multiple marketing applications and lifecycle management submissions from initial filing through to final approval.
The Legal Counsel will manage contract lifecycles, corporate governance, and entity maintenance across global jurisdictions. They will also provide legal advisory support, drive process automation, and collaborate with cross-functional teams on strategic initiatives.
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.
The Associate Contract Manager leads the review, negotiation, and finalization of contract templates and parameters while ensuring quality and risk assessment. They act as a regional interface for external clients and collaborate with internal departments to facilitate site startup activities.
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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.
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 Senior Compliance Specialist manages GxP regulatory authority inspections across the EMEA region, providing consultation on inspection readiness and preparation. They also support project teams in investigating non-conformances, developing CAPAs, and facilitating post-inspection follow-up activities.
![EDF power solutions is hiring for remote Senior Counsel - Real Estate [Remote]](/assets/9715bacc-cc9f-4cc5-9af7-f7d5a0613490.png){kind=small}
The Senior Counsel manages legal aspects of renewable energy project development, including real estate due diligence, land lease negotiations, and project financing support. They also advise business units on land acquisition and divestiture efforts while managing external legal counsel and corporate policies.
The Legal & Compliance Officer will support the Head of Legal in managing regulatory compliance, licensing obligations, and internal corporate policies. Responsibilities include conducting B2B KYC processes, monitoring responsible gambling activities, and assisting with internal and external audits.
The Compliance Officer will support legal and compliance operations, ensuring adherence to iGaming regulations, licensing requirements, and internal policies. Responsibilities include managing B2B KYC processes, drafting corporate documents, monitoring licensing obligations, and assisting with internal audits.
The Regulatory and Start Up Specialist serves as the single point of contact for site activation activities, ensuring adherence to regulations and project timelines. They are responsible for preparing and reviewing regulatory documents, maintaining internal databases, and coordinating with investigative sites and project teams.
The specialist ensures regulatory compliance with NERC Operations and Planning standards by managing internal compliance programs and supporting audit activities. They also coordinate with business units to resolve compliance issues and document potential violations for regulatory reporting.
The Regulatory Device CMC Manager supports strategies for marketed and development products by preparing and submitting regulatory CMC documentation for combination devices. The role provides guidance to cross-functional teams to ensure global regulatory requirements are integrated into development and commercial programs.
Translate and proofread patent-related content from English US into Serbian Cyrillic, specifically within the field of Biology. Ensure the original meaning is conveyed accurately and readably while following specific client style guides and CAT tool instructions.
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Translate and proofread patent-related content from English US into various European languages, specifically within the field of Biology. Ensure the original meaning is conveyed accurately and is readable for the target audience while following specific style and process instructions.
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.
Manage and track regulatory submissions for clinical trials in Serbia, ensuring compliance with local and international regulations. Liaise with project teams to provide strategic guidance on documentation, labeling, and regulatory intelligence.
The Regulatory CMC Manager supports global regulatory CMC strategies for cell and gene therapy products during development and commercialization. This includes preparing regulatory documentation and providing guidance to cross-functional teams on compliance and GMP investigations.
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 Principal Regulatory Affairs Specialist will lead global regulatory strategies for clinical trials and act as a primary liaison with internal and external clients. They are responsible for coordinating regulatory submissions, managing project teams, and representing the department in client and regulatory agency meetings.
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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