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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.
![EDF power solutions is hiring for remote Independent Systems Operator (ISO) Compliance Specialist [Remote]](/assets/9715bacc-cc9f-4cc5-9af7-f7d5a0613490.png){kind=small}
The specialist oversees regulatory compliance across U.S. ISO/RTO markets, with a primary focus on ERCOT nodal protocols and market rules. They are responsible for managing filings, conducting internal audits, and serving as the primary liaison for regulatory bodies and market surveillance.
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 role involves owning and scaling the partner ecosystem strategy, including managing vendor relationships and onboarding new content partners. You will oversee end-to-end course creation workflows while ensuring compliance, quality standards, and operational efficiency across the platform.
Support legal operations and onboarding processes for international banking and payment service providers. Review draft agreements and manage business correspondence to ensure compliance with internal policies and legal risks.
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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.
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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