Senior Technical Policy Regulatory Engineer jobs in London – Browse 4,162 openings on RoboApply Jobs

Senior Technical Policy Regulatory Engineer jobs in London

Open roles matching “Senior Technical Policy Regulatory Engineer” with location signals for London. 4,162 active listings on RoboApply Jobs.

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company3 Faces Recruitment Limited logo
Full-time|On-site|South West London

Join our client, a leading and rapidly expanding consultancy dedicated to enhancing consumer access to cutting-edge technology. This is an exciting opportunity to take on a management role within the organization. With a diverse international clientele, including both technology giants and innovative start-ups, you will have the chance to contribute to various international projects for some of the industry's most prominent companies.Job Overview:Our client is looking for a seasoned senior consultant capable of shaping the future of the technology sector amid continuous transformations. The ideal candidate will possess a robust history of effectively coordinating frequency usage for diverse radio services, facilitating the launch of new products and services, and influencing the associated regulatory frameworks.This role demands proven leadership abilities, outstanding analytical and communication skills, and a knack for distilling complex information into clear, concise presentations. Candidates should have a solid track record in managing and delivering on existing and new client accounts, with the willingness to travel internationally as needed.

Jan 22, 2020
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companyKKR & Co. Inc. logo
Full-time|On-site|London

COMPANY OVERVIEWKKR, a premier global investment firm, specializes in alternative asset management along with capital markets and insurance solutions. Our mission is to deliver compelling investment returns through a patient, disciplined approach, leveraging the expertise of world-class professionals, and fostering growth in our portfolio companies and the communities we engage with. We manage investment funds focusing on private equity, credit, and real assets, and collaborate with strategic partners for hedge fund management. Our insurance subsidiaries, under Global Atlantic Financial Group, provide retirement, life, and reinsurance products.TEAM OVERVIEWThe Public Policy & Affairs (PPA) function at KKR is pivotal in shaping and executing the firm’s global public policy, regulatory, and external engagement strategies. This includes the KKR Global Institute, which is dedicated to analyzing geopolitical risks, along with regional policy teams across the Americas, EMEA, and Asia-Pacific. The PPA team plays an essential role in safeguarding and enhancing KKR’s operational legitimacy by:Proactively anticipating regulatory and geopolitical changesAdvising investment teams on policy-related risks and prospectsAssisting portfolio companies in navigating complex stakeholder landscapesEngaging with governmental entities, regulators, and industry associationsOur team operates at the nexus of investing, policy, and reputation, directly influencing investment outcomes and fostering long-term value creation.POSITION SUMMARYKKR is on the lookout for a Senior Associate / Principal to join its EMEA Public Policy & Affairs team in London, reporting directly to the Head of EMEA Public Policy & Affairs. This individual will be instrumental in providing guidance on policy and regulatory matters, supporting investment activities, and enhancing strategic interaction with government and external stakeholders across the EMEA region. The role offers substantial exposure to senior leadership, positioning you at the intersection of investment decision-making, geopolitics, and stakeholder management.RESPONSIBILITIESMonitor and evaluate legislative, regulatory, and geopolitical developments across EMEAProvide strategic insights to investment teams and leadership on policy-related risks and opportunitiesMaintain a forward-looking perspective on trends affecting private capitalIdentify and mitigate potential risks to KKR’s operational environment

Apr 8, 2026
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companyNeko Health logo
Full-time|On-site|London

MissionAt Neko Health, our mission is to revolutionize healthcare by transitioning from illness treatment to proactive prevention. We leverage innovative, non-invasive technology and clinical expertise to provide early, actionable health insights.Position OverviewWe invite you to join Neko Health as a Senior Regulatory Affairs Engineer. Are you eager to influence the future of medical technology? We are on the lookout for a dedicated professional who excels in navigating complex regulatory frameworks, thrives in a fast-paced, collaborative setting, and is passionate about working with pioneering medical devices.We seek candidates with extensive expertise in software development, artificial intelligence, and machine learning within the medical device sector.Key ResponsibilitiesEnsure Regulatory Compliance: Guarantee that our advanced software adheres to global regulatory standards, aligning regulatory strategies from R&D to market launch and post-market activities.Implement AI/ML Regulations: Oversee the integration of regulatory requirements into AI and ML algorithms and device software, ensuring compliance throughout our processes.Support Software Development: Provide regulatory guidance during the software lifecycle, influencing design architecture, risk management, supplier selection, and labeling.Documentation Preparation: Engage in creating essential software documentation for our modules, components, algorithms, and devices as required.Empower Teams: Assist process owners and product teams in incorporating regulatory requirements into our Quality Management System and deliver effective training on compliance and regulatory matters.Stay Informed: Track regulatory trends and provide insights to keep Neko Health at the leading edge of compliance.QualificationsEducation: Bachelor’s or Master’s degree in law, medicine, pharmacy, engineering, or a related field.Experience: 4–5+ years of experience in software development with a focus on artificial intelligence and machine learning within the medical device industry.

Jan 28, 2026
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companyNeko Health logo
Full-time|On-site|London

MissionAt Neko Health, our mission is to revolutionize healthcare by transitioning from a reactive approach to a proactive one, utilizing state-of-the-art, non-invasive technology alongside clinical expertise to provide early and actionable health insights.Are you prepared to influence the future of medical technology? We are in search of a Senior Regulatory Affairs Engineer who is enthusiastic about implementing intricate regulatory strategies, has a passion for working with innovative medical devices, and excels in a dynamic, collaborative, and distributed environment.We seek candidates with extensive experience in managing active medical devices and software as a medical device throughout their entire product lifecycle.Your ResponsibilitiesRegulatory Leadership: Ensure our innovative medical devices comply with global standards and regulations, aligning regulatory strategies from R&D through to market entry and post-market activities.Product Development Support: Provide guidance on regulatory strategy during the product lifecycle, impacting design, risk management, supplier selection, and labeling.Regulatory Documentation Management: Create and maintain essential regulatory documentation, including Design History Files (DHF), Technical Documentation, Device Master Records (DMR), and Device History Records (DHR).Regulatory Submissions Management: Prepare, review, and submit documentation for EU MDR, FDA, and other international markets.Product Safety Monitoring: Engage in post-market surveillance, CAPA, and complaint management activities.Engagement with Regulatory Authorities: Facilitate communication with regulatory bodies, managing certification projects and vigilance activities to ensure timely compliance and reporting.Empowerment of Teams: Assist process owners and product teams in integrating regulatory requirements within our Quality Management System and deliver training on compliance and regulatory matters.Regulatory Trend Monitoring: Stay updated on regulatory trends, providing insights to keep Neko Health at the forefront of compliance.Your QualificationsSignificant experience in regulatory affairs within the medical device or healthcare technology sector.Deep knowledge of global regulatory standards, including EU MDR and FDA requirements.Strong communication, analytical, and problem-solving skills.Ability to thrive in a fast-paced, collaborative environment.

Jan 28, 2026
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company
Full-time|From £44.3K/yr|On-site|London, England, United Kingdom

Salary: Starting from £44,340 + benefitsRole Duration: PermanentOverview - What You Will AchieveThe Academy of Medical Sciences’ FORUM serves as a neutral, independent platform that unites leaders from research, industry, the health system, charities, and government. This collaboration aims to share insights, exchange evidence, and devise solutions to the complex challenges faced in health and life sciences. Key priorities for this role include:Enhancing health outcomes both in the UK and internationally.Mobilizing the UK health research system to translate discoveries into practical applications.Positioning the UK as the premier destination for medical science careers.As a Senior Policy Officer, you will play a crucial role in shaping and delivering a high-impact cross-sector program, ensuring that the Academy convenes the right stakeholders at the right time and on critical issues. In the upcoming year, your focus areas may include prevention and early detection, leveraging clinical evidence to accelerate the translation of discoveries to patient impacts, promoting the inclusion of underrepresented groups in research, and exploring the role of AI and data in biomedical sciences.Your responsibilities will include leading a portfolio of policy meetings and workshops, producing influential outputs, and fostering relationships within the FORUM network. You will leverage evidence, stakeholder insights, and sound judgment to guide decisions on the Academy's strategic focus, maximizing impact while upholding the high standards and values that define our work.This position presents a unique opportunity to influence discussions across the life sciences field and contribute to improving health through evidence-informed policy initiatives.Role Responsibilities - What You Will DoPolicy Insight and Cross-Sector ContributionAssist the FORUM Policy Manager in developing an annual program aligned with organizational priorities and emerging health challenges.Utilize evidence and stakeholder insights to identify areas where cross-sector collaboration can deliver the most value.Contribute to enhancing the Academy’s reputation as a leading, evidence-driven convener on complex health issues.Program Oversight & DeliveryOversee the planning and execution of FORUM policy meetings, workshops, and events (in-person, hybrid, and digital), ensuring smooth operations, high-quality content, and an exceptional experience for all participants.Create briefing materials, agendas, and meeting reports that clearly synthesize evidence and stakeholder perspectives.Proactively identify and manage risks, ensuring events are inclusive, accessible, and delivered to the highest standard.

Mar 25, 2026
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companyTaboola logo
Full-time|On-site|London, United Kingdom

Unleash your potential by becoming a part of the leading performance-driven advertising company! As our Policy Director, you will play a pivotal role in shaping the global policies that govern our dynamic ecosystem. Your mission is to transform the policy function from a reactive entity into a proactive research and development powerhouse. Reporting directly to the Head of Integrity & News Operations, you will establish standards that ensure marketplace health while balancing network integrity with robust commercial growth. This role is ideal for strategic visionaries who can navigate complex regulatory landscapes and turn them into sustainable competitive advantages.

Mar 16, 2026
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company
Full-time|From £44.3K/yr|Hybrid|London, England, United Kingdom

Salary: Starting from £44,340 + benefitsRole duration: Permanent (37.5 hrs/week)Location: London, UK (Hybrid - 50% office attendance)Summary Purpose – what you will be achieving: As a vital member of the Academy’s Policy Team, the Senior Policy Officer will be instrumental in shaping the organization’s strategic direction. This position is key in helping the Policy team formulate and implement new priorities for 2026/27, which include:Enhancing health outcomes both in the UK and globally.Harnessing the UK health research system to translate discoveries into practical applications.Positioning the UK as the premier destination for careers in medical sciences.In alignment with these priorities, the incoming Senior Policy Officer will engage in distinct policy programs, which may encompass:Maximizing the impact of medical sciences in prevention and early detection initiatives.Revolutionizing the generation and application of clinical evidence to accelerate the translation from discovery to patient benefits, ensuring equitable inclusion of underserved populations.Establishing the UK as a global leader in responsible, effective, and equitable use of AI and data within the biomedical sciences.Conducting foresight exercises to identify and support high-impact innovations critical to the future of health systems.The Senior Policy Officer will report directly to a Policy Manager.About the role – what you will be doing: Core policy workLead and support various policy projects to inform and influence the policy landscape in alignment with Academy priorities. This work may include:Major working group studies and producing relevant outputs.Responding to government initiatives and announcements.Engaging in consultations, rapid responses, and drafting concise position papers.Facilitating roundtables, workshops, and other significant policy events.Preparing correspondence and briefings for senior stakeholders.Collaborate closely with Academy Fellows and other experts to identify and analyze critical policy issues, gather data, and form impactful recommendations for internal and external stakeholders.Implement and follow up on policy recommendations across diverse external audiences.Maintain a comprehensive understanding of the policy landscape to drive effective initiatives.

Apr 2, 2026
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companywise logo
Full-time|On-site|London

Join wise as a Senior Regulatory Oversight Manager in our Advisory team, where you will play a pivotal role in ensuring compliance and effective governance across our operations. As a key leader, you will oversee regulatory activities, drive strategic initiatives, and collaborate with cross-functional teams to maintain high standards of regulatory adherence.

Apr 13, 2026
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companySpotify Technology S.A. logo
Full-time|On-site|London

Spotify is hiring a Senior Staff Machine Learning Engineer for its Content Platform team in London. This group oversees the entire lifecycle of content on Spotify, from music and podcasts to audiobooks and emerging formats. Their mission: keep every piece of content trusted, safe, and high quality for millions of listeners worldwide. Key responsibilities Design and scale machine learning systems that focus on content safety, policy enforcement, and compliance throughout Spotify’s platform. Shape automated systems that evaluate and act on content, with an emphasis on consistency, transparency, and reliability at a global scale. Contribute to systems for ingesting, enriching, managing, and distributing both licensed and user-generated content. Support trust with listeners and creators by ensuring content remains safe and compliant as Spotify’s platform grows and diversifies. The team The Content Platform team builds and maintains the systems that manage every stage of content on Spotify. The group adapts to new content types and meets challenges introduced by advances in AI and creation tools. Their work centers on technology and processes that support safety, compliance, and quality for a global audience. Location This role is based in London.

Apr 28, 2026
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companyMilltown Partners logo
Full-time|On-site|London

Join Milltown Partners as a Policy Communications Adviser in our vibrant London office, where you will lead innovative policy communications strategies for pioneering technology firms tackling complex challenges across the UK and Europe. We seek dynamic professionals with a passion for public policy and a minimum of 5 years of relevant experience looking for an exciting new chapter in their careers.THE ROLE OF THE ADVISERAs a key member of our team, you will act as a trusted advisor, adept at enhancing the reputation of our clients through strategic communications aligned with their goals. Your expertise will be crucial in addressing commercial challenges while fostering Milltown Partners’ growth and innovation in the policy communications arena. You will collaborate with team members to leverage collective skills, mentor junior colleagues, and step in for Directors and Partners as needed.Successful candidates will possess the ambition, expertise, and networking capabilities to offer tailored policy communications guidance to our tech clients on both a UK and European scale.KEY RESPONSIBILITIESStrategic Development: Formulating and implementing communications strategies that influence the discourse on policy issues.Collaborate with client leads to define strategic priorities for their projects.Develop comprehensive policy communications plans to ensure effective strategy execution.Transform technical and policy information into engaging narratives that resonate with diverse stakeholders including media, policymakers, regulators, and the public.Utilize thorough knowledge of communication channels and audiences to effectively position clients and tell their stories.Create and refine client requests, ensuring all advice is grounded in insights.Customize the style and content of advice to align with client expectations.Engage confidently in discussions regarding AI-enhanced solutions, demonstrating added value.Proactively suggest innovative solutions that exceed client expectations.Advisory Role: Building trust with clients and delivering clear, actionable recommendations.Provide advice in various formats, selecting the most impactful method for each client at the appropriate time.Generate compelling written materials and lead significant communication initiatives such as media briefings, speeches, and events.Stay informed on a wide range of content, from government consultations to research papers.

Sep 30, 2025
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companyzip logo
Full-time|On-site|London

Join zip as a Senior Technical Support Engineer and play a pivotal role in ensuring our customers receive unparalleled technical assistance. You will be responsible for troubleshooting complex issues, guiding customers through technical challenges, and providing exceptional support. This position requires a proactive and problem-solving mindset, as well as the ability to work collaboratively in a fast-paced environment.

Feb 25, 2026
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companySuade logo
Full-time|On-site|London, England, United Kingdom

At Suade, our remarkable journey is fueled by determination and our innovative technology that is paving the way for the future of RegTech. The RegTech team is pivotal to our product development and essential for our sustained business growth.In your role as a Senior Regulatory Reporting Specialist, you will leverage your extensive regulatory reporting experience to spearhead the design, development, and enhancement of our reporting portfolio, collaborating closely with our product team.Suade is proud to be an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all qualified applicants without bias.Key Responsibilities: Lead a range of client-facing implementation projects, defining business requirements (including new products and regulations) and assisting clients with data mapping to the FIRE data schema. Manage and mentor a team of graduate Business Analysts. Act as the subject matter expert for a specific family of regulatory reports, staying informed on regulatory changes and collaborating with clients and industry experts. Provide expert guidance in the creation and updates of regulatory returns in partnership with our Lead Engineers. Support the Customer Success team by addressing client queries in business-as-usual conditions. Enhance and develop documentation and training materials for clients and internal stakeholders. Elevate Suade’s visibility in the regulatory landscape, collaborating with our Sales and Marketing teams for presentations and events that require regulatory knowledge.

Jan 21, 2026
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companySemgrep logo
Full-time|Remote|London Hub

About SemgrepSemgrep is a leading innovator in code security, designed to empower developers to create with confidence. Our platform enables teams to identify, flag, and resolve genuine security issues before deployment, leveraging adaptive security that evolves as they code. Semgrep provides real-time coding protection and insights, allowing developers to maintain their pace without compromising security. With its learning AI, Semgrep minimizes false positives and prioritizes actionable vulnerabilities, earning the trust of 95% of security reviewers across over 6 million findings. Our solutions significantly reduce the burden on AppSec teams, allowing them to focus on critical tasks.Founded in San Francisco and supported by top-tier venture firms including Menlo Ventures and Sequoia Capital, Semgrep is recognized by Gartner for its excellence in Application Security Testing. We are proud to serve renowned clients like Snowflake, Dropbox, and Figma. Discover more at semgrep.dev.About the RoleThe Senior Technical Support Engineer (TSE) plays a vital role within our Customer Success Organization. In this position, you will engage with existing and potential clients to swiftly diagnose, replicate, and resolve technical issues. Acting as the primary contact for support inquiries via email, Slack, and support cases, you will address challenges related to our Semgrep product suite, including Semgrep SAST, Supply Chain, and Secrets solutions. This customer-facing role offers exposure to various teams within Semgrep, such as Engineering, Product Management, and Sales, creating ample opportunities for professional growth in a dynamic environment.Location Expectations: This role is fully remote, with the requirement that the candidate is based in the UK.We value problem-solving skills over specific backgrounds. If you find this role exciting but do not meet all the criteria, we encourage you to apply!Key ResponsibilitiesAnalyze, reproduce, and resolve complex technical issues raised by customers.Manage customer inquiries from initial creation to resolution.

Mar 10, 2026
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companyClear Street logo
Full-time|On-site|London, UK

About Clear Street:Clear Street is dedicated to democratizing access to every asset across various markets through a unified platform engineered for speed, transparency, and scalability. We equip our clients with cutting-edge technology and services previously exclusive to the largest financial institutions, all built on modern infrastructure. Our comprehensive, cloud-native capital markets platform not only supports investor growth today but also revolutionizes market interactions for tomorrow.For further details, visit https://clearstreet.io. The Team:The Regulatory Reporting Engineering team at Clear Street is a dedicated group with significant responsibilities. We collaborate closely with stakeholders to ensure timely compliance with financial and regulatory obligations, striving to streamline their processes through innovative, automated solutions. As Clear Street expands into new product lines and regions, every team member has the opportunity to make a substantial impact. Join us to contribute meaningfully, collaborate with skilled professionals, and work with state-of-the-art technology to enhance operational excellence. The Role:As the Lead Software Engineer on the Regulatory Reporting Engineering team, you will be crucial in automating our Compliance & Finance regulatory processes. Utilizing your analytical abilities, you will develop solutions that process extensive data sets from our data warehouse to produce accurate, comprehensive reports, including reconciliation processes.You will work alongside key stakeholders from Compliance, Finance, and Treasury to grasp regulatory and financial requirements, translating them into clean designs and scalable solutions. As the technical lead for the team, you will provide guidance, prioritize tasks, engage in hands-on design and development, conduct code reviews, and evolve our technical standards and best practices. Tech Stack: Python, SQL, Snowflake, Retool, Docker, Kubernetes...

Mar 5, 2026
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companySuade logo
Full-time|Remote|London, England, United Kingdom

At Suade, we pride ourselves on our resilience and innovative spirit, developing state-of-the-art technology that defines the future of RegTech. Our Regulatory Product team is pivotal to our operations, playing an instrumental role in driving our business forward.As a Senior Regulatory Change Implementation Specialist, you will leverage your extensive experience in regulatory reporting to spearhead the design, development, and enhancement of our reporting portfolio in collaboration with our product team.Key Responsibilities:Serve as a primary contact for regulatory inquiries from both internal teams and clients.Monitor and evaluate regulatory changes, assessing their implications on current reporting obligations.Conduct impact assessments to define scope, timelines, interdependencies, and potential risks.Interpret complex regulatory requirements, translating them into clear and actionable product and business specifications.Oversee a range of client-focused implementation projects, outlining business needs for new products and regulations.Act as a subject matter expert on critical regulatory frameworks, offering insights to internal stakeholders.Review regulatory logic, calculations, and outputs to ensure accuracy and compliance.Collaborate closely with Product and Engineering teams to refine implementation strategies and communicate requirements effectively.Create and enhance documentation and training materials for clients and internal teams.Mentor junior Implementation Specialists and Engineers, imparting your regulatory expertise.Enhance Suade’s visibility in the regulatory domain and collaborate with Sales and Marketing teams for presentations and events requiring regulatory insights.Identify enhancements to existing reports and expand regulatory coverage.Contribute to the regulatory product roadmap with insights, recommendations, and forward-looking analysis.Stay informed about industry trends and evolving regulatory standards.This role offers the flexibility to be based anywhere in the UK.

Mar 25, 2026
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companyMilltown Partners logo
Full-time|On-site|London

Join Milltown Partners as a Communications & Policy Analyst, where you will play a pivotal role in shaping strategic communication initiatives and influencing policy decisions. Your analytical skills will be crucial in delivering insightful research and crafting compelling narratives that resonate with various stakeholders.

Jul 18, 2024
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company3eco logo
Full-time|On-site|London, UK

3eco is hiring a Regulatory Solutions Advisor in London. This role centers on helping clients navigate regulatory compliance. The position calls for a strong understanding of regulations and the ability to adapt solutions to different client situations. Role overview The Regulatory Solutions Advisor works closely with clients to interpret and address regulatory requirements. The focus is on providing practical guidance and ensuring compliance strategies fit each client’s business context. What you will do Advise clients on regulatory compliance matters Develop and recommend solutions tailored to individual client needs Support the ongoing improvement of compliance practices Requirements Expertise in regulatory compliance Ability to understand and address varied client needs Strong communication and problem-solving skills

Apr 29, 2026
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companyMan Group logo
Contract|On-site|London

About Man GroupMan Group is a leading global alternative investment management firm dedicated to delivering superior returns for sophisticated clients through our diverse Systematic, Discretionary, and Solutions offerings. With a strong emphasis on leveraging talent and cutting-edge technology, our investment strategies encompass both single and multi-manager approaches, underpinned by extensive research across public and private markets and all major asset classes, particularly in alternatives. We pride ourselves on building deep partnerships with clients to create customized solutions tailored to their investment aspirations and those of the millions of retirees and savers they represent.Headquartered in London, we manage an impressive portfolio of $227.6 billion* and maintain offices worldwide. Man Group plc is publicly traded on the London Stock Exchange under the ticker EMG.LN and is a member of the FTSE 250 Index. More details can be found at www.man.com.* As of 31 December 2025Role Overview:This role, situated within Man Group’s Finance department, reports to the Head of Financial and Regulatory Reporting. Key responsibilities include the calculation, review, and monitoring of regulatory capital and liquidity requirements, alongside regulatory returns; overseeing guarantees and commitments; and assisting with technical accounting evaluations, including new lease arrangements. This position also allows for engagement in financial accounting and group reporting analysis and deliverables as needed. Please note this is a 6-month fixed-term contract (FTC).

Mar 31, 2026
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company
Full-time|On-site|London

Join Three UK as a Senior Counsel specializing in Regulatory Implementation, where you will play a pivotal role in navigating the complexities of telecommunications regulations. Your expertise will ensure compliance and drive strategic initiatives in regulatory matters.

Mar 18, 2026
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company
Director of Regulatory Science

Orchard Therapeutics

Full-time|On-site|London, England, United Kingdom

Location: London, UKReporting to: VP, Regulatory Science Orchard Therapeutics, a subsidiary of Kyowa Kirin, is a pioneering leader in the field of gene therapy, dedicated to changing the lives of patients suffering from rare disorders. Our innovative gene therapies leverage gene-modified hematopoietic stem cells (HSCs) to make a transformative impact. With our global headquarters based in London and a U.S. presence in Boston, we are at the forefront of scientific advancement.Job SummaryThis is an extraordinary opportunity to become a key player in a dynamic team focused on shaping the global regulatory strategy and executing regulatory activities for promising early-stage ex-vivo gene therapy assets. We are seeking a candidate with a robust regulatory background who can craft innovative strategies while demonstrating exceptional collaboration, problem-solving, and attention to detail to drive groundbreaking scientific endeavors.Key ResponsibilitiesServe as the Global Regulatory Lead for assigned ex vivo gene therapy programs:Represent the regulatory function on cross-functional program teams.Collaborate with the program lead and development team (including research, preclinical, and/or clinical stakeholders) to design a development strategy aimed at securing regulatory approvals.Lead the formulation of global regulatory strategies and oversee the execution of planned regulatory activities across regions (including but not limited to the EU and US) in conjunction with the broader regulatory team, facilitating timely initiation of pivotal studies and an expedited approval pathway.Oversee US FDA regulatory efforts to achieve global development and registration in alignment with US counterparts.Work closely with the Regulatory CMC lead to formulate effective regulatory strategies related to CMC development.Act as the regulatory liaison with academic partners and coordinate regulatory activities with them as necessary.Function as the EU/UK Regulatory Regional Lead, directing the execution of EU/UK regulatory activities for assigned programs:Plan, prepare, and review submissions to regulatory authorities (including EMA and other national bodies):Manage or supervise initial clinical trial applications (CTA) submitted to national regulatory authorities in EU/UK and subsequent submissions necessary for maintaining ongoing clinical trials in collaboration with CROs.Oversee applications for orphan designation (OD), PRIME designation, scientific advices, pediatric investigation plans (PIP), pre-submission meetings, etc.Act as the primary contact with regulatory authorities.Prepare scientific advice/pre-submission meeting requests, briefing documents, and coordinate team preparations for meetings.

Feb 13, 2026

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