Regulatory Solutions Advisor jobs in London – Browse 842 openings on RoboApply Jobs

Regulatory Solutions Advisor jobs in London

Open roles matching “Regulatory Solutions Advisor” with location signals for London. 842 active listings on RoboApply Jobs.

842 jobs found

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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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companyMatch Performance Solutions Ltd logo
Senior Business Analyst - Regulatory Change

Match Performance Solutions Ltd

Contract|£75K/yr - £85K/yr|On-site|London

Senior Business Analyst - Regulatory ChangeLocation: LondonSalary: £75,000 - £85,000 (Fixed Term Contract)At Match Performance Solutions Ltd, we are dedicated to making a significant impact. Our mission is rooted in the belief that we can help our clients achieve their capability goals more effectively than traditional consultancies. We blend extensive experience, insightful perspectives, and innovative technology to tackle the challenges our clients encounter. Our proven solutions have been successfully implemented numerous times and continue to evolve as technology advances.The landscape of change management is increasingly intricate, rendering many experienced Change professionals struggling to meet new demands. As businesses become more reliant on the speed and efficacy of program and project delivery, the pressure on Change functions has never been greater.Our Commitment:Providing high-level delivery resources - whether architecting or executing ambitious goals.Coaching and training to nurture internal talent.Delivering data and insights to share successes and failures, offering a foundation for future improvements.Attracting top-tier talent from the marketplace.Providing consultancy to enhance organizational capabilities.Key Responsibilities:Exemplary stakeholder management across all levels, both internally and externally.A minimum of 3 years of experience in Business Analysis.Acting as a liaison between business units and IS, employing exceptional written and verbal communication skills to ensure clear translation of business requirements into functional outcomes.Demonstrating strong business acumen, quickly acquiring the necessary content and knowledge to support the business throughout the requirements gathering, design, and testing phases.Producing comprehensive and precise documentation (e.g., process mapping, data flow diagrams), and facilitating workshops using various business analysis techniques including GAP analysis, requirements gathering, and validation.Qualifications:Experience managing complex projects and programs involving extensive business change.Able to navigate uncertain or challenging environments, providing constructive challenges as needed.Consistently producing high-quality outputs that meet management standards.Familiarity with both agile and waterfall project life cycles within a structured environment, with experience collaborating with third-party application developers.Experience in developing business processes and employing innovative thinking to challenge existing practices.A proactive thinker with strong influencing skills, capable of recognizing when to escalate or seek support for critical issues.

Jan 14, 2019
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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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company
Full-time|On-site|London

Join Three UK as a Regulatory Lead and play a pivotal role in shaping our regulatory strategies. You will be at the forefront of navigating complex regulatory landscapes, ensuring compliance, and advocating for our interests in the telecommunications sector.

Apr 8, 2026
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company
Full-time|On-site|London

Join Three UK as a Regulatory Manager, where you will play a vital role in shaping our regulatory strategies and ensuring compliance with industry standards. You will collaborate with various stakeholders to develop and implement policies that support our business objectives while adhering to regulatory requirements.

Apr 10, 2026
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companyIQEQ logo
Full-time|On-site|London

Join IQEQ, a leader in regulatory compliance, as a Regulatory Compliance Consultant. This is a fantastic opportunity for individuals looking to advance their careers in a dynamic environment.As a Compliance Consultant, you will be pivotal in helping our clients meet their regulatory obligations and navigate the complexities of compliance frameworks. You will work closely with our Client Services department to deliver tailored solutions that align with our clients' needs.

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

About AboundAt Abound, we are revolutionizing consumer lending across the UK and beyond. By harnessing the power of advanced AI and Open Banking data, we deliver fair and affordable personal finance solutions to a broader audience. Unlike traditional lenders, who primarily focus on credit scores, we assess the complete financial landscape of our customers—considering their spending habits and repayment capabilities to create a comprehensive understanding of each individual's unique financial needs.Our innovative approach has proven effective at scale; we've successfully issued over £1.3bn in loans, achieving industry-leading credit performance. For every 10 defaults expected in the industry, we experience only 3. Our growth trajectory is exceptional, achieving profitability just 2.5 years after our inception.Supported by over £2bn in funding from prominent investors such as Citi, GSR Ventures, and Deutsche Bank, we have been recognized as one of Europe’s fastest-growing fintech companies (Sifted, CNBC). As we continue to expand into new markets and product lines, we are on the lookout for ambitious individuals who are eager to learn, take ownership, and grow alongside us.Role SummaryAs we scale our operations, we are seeking a Regulatory Counsel with expertise in the Consumer Credit Act (CCA) and FCA CONC regulations. Your role will involve preparing submissions to the FCA and other regulatory bodies while advising senior leadership on regulatory risks pertinent to your area. You will also be responsible for drafting, implementing, and monitoring legally sound, plain-English templates, ensuring that live documents are consistent with approved versions. Given our small legal team, you will also assist with a variety of broader legal tasks.Key ResponsibilitiesRegulatory Submissions: Craft high-quality submissions and supporting documents, including Appointed Representative/IAR applications, waiver/modification requests, and applications for new permissions, while collaborating with external counsel as necessary.New Market Analysis: Identify and communicate critical legal and regulatory issues related to new products, markets, and geographies under consideration. Collaborate closely with cross-functional teams to ensure that decisions regarding new market entries are well-informed and effectively managed.Draft and Maintain Customer Credit Documentation: Oversee the lifecycle of customer credit documentation (pre-contract and post-contract), including credit agreements, PCCI, adequate explanations, statements, and notices (e.g., NOSIAs and Default Notices). Manage the suite of customer documentation, ensuring proper version control and approvals.

Feb 23, 2026
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companyLewis Associates logo
Regulatory Attorney

Lewis Associates

Full-time|On-site|London

Join Lewis Associates as a Regulatory Attorney in our London office. We are looking for a dedicated legal professional to help navigate complex regulatory frameworks and ensure compliance with industry standards. This is an exciting opportunity to work in a dynamic environment where your expertise will influence significant business decisions.

Mar 24, 2014
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companySuade logo
Full-time|Remote|London, England, United Kingdom

At Suade, our journey of success is fueled by tenacity, innovation, and a relentless commitment to pioneering advanced technology in the RegTech sector. Our Regulatory Product team plays a pivotal role in driving our product vision and fostering sustained business growth.In your role within the Regulatory Product team, you will leverage your extensive expertise in regulatory reporting to steer the architecture, development, and enhancement of our report portfolio, collaborating closely with our product team.Key Responsibilities:Monitor and analyze regulatory changes, assessing their implications for existing reporting obligations.Translate complex regulatory texts into structured business and product requirements.Engage in client-facing implementation projects, defining requirements for new products and regulations.Provide specialized knowledge in developing and updating regulatory returns in collaboration with our Lead Engineers.Create and refine documentation and training materials for both clients and internal teams.Guide and mentor junior Implementation Specialists and Engineers using your regulatory insights.Assist in testing and validating regulatory outputs to ensure compliance and data integrity.Enhance Suade’s reputation in the regulatory domain by collaborating with our Sales and Marketing teams during presentations and events requiring regulatory expertise.Stay informed about industry trends and evolving regulatory frameworks.This position is open to candidates based anywhere in the UK.

Mar 25, 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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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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companyAlixPartners logo
Full-time|Hybrid|London

At AlixPartners, we tackle the most intricate and pressing challenges by swiftly transitioning from analysis to actionable solutions when it truly matters; generating value that leaves a lasting mark on corporations, their workforce, and the communities they engage with. Our commitment to understanding, respecting, and honoring the diverse needs of our employees, clients, and communities fosters an inclusive environment. We firmly believe in the enriching impact of diversity on our experiences and are dedicated to the continuous improvement of our initiatives, policies, and practices. We hold ourselves accountable by providing a platform for authenticity, growth, and equity for all. Embracing a hybrid work model, AlixPartners offers flexibility to support our employees' work-life balance. Our approach combines a blend of in-person work (either at client sites or AlixPartners offices) and remote work. While travel is a component of this role, its frequency will vary based on client needs, team dynamics, and individual situations.

Mar 9, 2026
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companyAirwallex logo
Full-time|On-site|UK - London

About AirwallexAirwallex stands as a pioneering unified payments and financial platform, specifically designed for global enterprises. Our unique blend of proprietary infrastructure and advanced software solutions empowers over 200,000 businesses globally, including notable names like Brex, Rippling, Navan, Qantas, and SHEIN. Through our comprehensive offerings, businesses can efficiently manage everything from accounts and payments to spend management and treasury operations, along with embedded finance capabilities on a global scale.Founded in Melbourne, Airwallex boasts a diverse team of over 2,000 exceptionally talented individuals spread across 26 global offices. With a valuation of US$8 billion and the support of prominent investors such as T. Rowe Price, Visa, Mastercard, Robinhood Ventures, Sequoia, Salesforce Ventures, DST Global, and Lone Pine Capital, we are at the forefront of developing the future of global financial services. If you are prepared to embark on the most ambitious endeavor of your career, we invite you to join our team.Attributes We ValueWe seek innovators with a builder's mindset, eager to make a real impact, accelerate their learning, and take ownership of their work. You possess deep expertise in your field, coupled with sharp analytical skills, and are driven by our mission and operating principles. You work swiftly with sound judgment, explore deeply with curiosity, and make decisions based on fundamental principles, balancing efficiency with thoroughness.Humility and collaboration are vital traits for us; we expect you to transform innovative ideas into tangible products and effectively drive projects from inception to completion. Utilizing AI to enhance your efficiency and expedite problem-solving is key. In this role, you will address intricate, high-profile challenges alongside an exceptional team and experience significant professional growth as we redefine global banking. If this resonates with you, let’s create the future together.Role SummaryYou will take charge of global regulatory reporting across all jurisdictions, ensuring submissions are accurate, timely, and comprehensive. You will lead the regulatory reporting function, spearhead enhancements to the automated reporting platform, uphold strong governance and internal controls, and act as the main liaison between Compliance/Legal, Operations, Finance, Risk, Data, Product, and Technology to guarantee data integrity and prepare for audits. Additionally, you will proactively monitor regulatory changes, evaluate their impact, and drive implementation to ensure our reporting processes and systems maintain compliance and scalability.

Mar 20, 2026
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company
Regulatory Affairs Analyst

Pension Insurance Corporation

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

Pension Insurance Corporation (PIC) is dedicated to providing secure retirement income through meticulous risk management, superior asset and liability management, and outstanding customer service. Our mission is to ensure that pensions for our current and future policyholders are met effectively. We achieve this through strategic objectives and fostering a strong company culture rooted in our core values of Resilience, Adaptability, and Loyalty.Role OverviewJoin our Regulatory Affairs team, which operates within the Risk and Compliance function.Your contribution will help strengthen our regulatory risk management and deepen our understanding of regulatory challenges and initiatives across PIC.You will collaborate with various departments to integrate regulatory considerations into key business activities and decisions, enabling controlled risk-taking that fosters long-term value.The Regulatory Affairs team leads PIC’s regulatory strategy and manages relationships with key UK regulators (PRA and FCA), including addressing regulatory inquiries and providing strategic insights and recommendations.Your role will involve working closely with first line and risk colleagues to gain support and implement enhancements to systems, processes, and technologies, including:Applying insights about the Regulators' influence on PIC and policyholders.Conducting proactive horizon scanning to identify emerging trends and regulations to anticipate future needs and mitigate risks.Ensuring strong business outcomes related to capital, profitability, brand reputation, and consistent positive results.Our company values must be reflected in the performance and delivery of every role.Key Responsibilities as a Regulatory Affairs Analyst:Collaborate with the team to enhance regulatory engagement throughout the business, ensuring that our approach remains fit for purpose, efficient, and effective.Conduct detailed analysis of regulatory changes and support the team in advising the business on suitable actions.Assist in determining the timing and nature of responses to regulatory activities, including inquiries, thematic requests, and relevant consultations and policies.Gather, interpret, and utilize complex data to formulate actionable strategies that improve processes and outcomes.

Mar 26, 2026
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companyRipple logo
Full-time|On-site|London, UK

At Ripple, we are revolutionizing the way value is transferred globally, akin to the speed of information today. Our ambitious initiatives in cryptocurrency aim to enhance the financial landscape for institutions, businesses, governments, and developers, fostering economic equity and expanding opportunities worldwide. Join us in doing meaningful work while developing your skills alongside a supportive team.If you're eager to make a significant impact and tap into remarkable career advancement prospects, we invite you to join us in creating genuine value.THE ROLE:Ripple is expanding its Regulatory Compliance team and is on the lookout for a seasoned Regulatory Compliance Manager to become part of our dynamic global team. This position offers a unique chance to assist in the daily functions of our Business Continuity Management Program, ensuring operational resilience. Your contributions will be pivotal in the successful implementation of our program.KEY RESPONSIBILITIES:Oversee the identification and management of Important and Critical Business Services.Maintain a thorough mapping of personnel, processes, technology, and data, proactively addressing Single Points of Failure and concentration risks within Ripple’s crucial ICT third-party service providers.Define and calibrate Impact Tolerances and Recovery Objectives, establishing measurable metrics to ensure Ripple remains compliant during disruptions.Facilitate a comprehensive testing program across global jurisdictions to validate effective recovery strategies.Lead the annual business impact analyses and risk assessments, ensuring timely completion and maintenance.Support Crisis Management and Business Resumption teams, prioritizing service delivery and adherence to regulatory notification timelines.Prepare high-quality reports, KPIs, and presentation materials for Board and Risk Committees, offering a transparent view of Ripple’s global resilience status.Collaborate with various stakeholders to ensure robust internal oversight and governance across Ripple’s regulated entities.Complete special assignments within other Regulatory Compliance program areas as required.

Apr 9, 2026
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companyDelta Capita logo
Full-time|On-site|London, Greater London, United Kingdom

As a Regulatory Outsourcing Officer at Delta Capita, you will play a pivotal role in managing the governance, risk, and compliance framework for our third-party arrangements, ensuring stringent adherence to regulatory obligations.Key Responsibilities:Outsourcing Governance: Develop and implement outsourcing policies, frameworks, and procedures to minimize risks effectively.Regulatory Monitoring: Stay updated with the latest local and regional regulatory requirements (e.g., Central Bank of Ireland, EBA, FCA) and evaluate their implications on our business operations.Risk & Control: Oversee third-party vendors and service providers, facilitating due diligence and comprehensive risk assessments.Reporting: Create detailed reports and management information for committees and senior management as necessary.KPI Monitoring: Ensure high-quality monitoring of KPIs and identify proposed metrics for successful outsourcing controls while recognizing potential issues.Contract Negotiations: Assist in contract negotiations with service providers, coordinating with the legal department and relevant stakeholders.Risk Analysis Management: Conduct planning and risk analysis of outsourced arrangements, including effective communication and coordination with other functions.Ongoing Risk Management: Manage outsourcing risks, including concentration risks, on an ongoing basis.Provider Oversight: Coordinate meetings to address any shortcomings with outsourcing providers effectively.Outsourcing Register Maintenance: Keep the Outsourcing Register updated and promote awareness and training regarding outsourcing.Support Functions: Assist departments in designing monitoring and control measures, including annual status reports on outsourcing for management review.First Line of Defense: Oversee and coordinate outsourcing as the first line of defense control function.

Apr 8, 2026
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company
Full-time|On-site|London, England, United Kingdom

Role overview g-mass is hiring a Regulatory Business Analyst based in London. The position centers on maintaining compliance with regulatory requirements while supporting projects that improve business operations. Daily work involves close collaboration with teams across the company, analyzing how business processes function, and identifying areas where regulatory risks may arise. What you will do Partner with cross-functional teams to review and refine business processes Identify and evaluate regulatory risks within company operations Create strategies to address and minimize compliance risks Present findings and recommendations clearly to stakeholders at different levels Requirements Keen attention to detail Strong analytical and problem-solving abilities Ability to communicate effectively with both technical and non-technical colleagues Background in regulatory analysis or business process improvement considered an advantage

Apr 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 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|On-site|London, England, United Kingdom

Location: London, UKReporting to: Senior Director of Regulatory ScienceJob SummaryOrchard Therapeutics is a pioneering global biotechnology company focused on gene therapy, dedicated to transforming the lives of individuals impacted by rare diseases through the development of innovative cell and gene therapies. With our global headquarters situated in London and our U.S. office in Boston, we are a wholly owned subsidiary of Kyowa Kirin, a distinguished Global Specialty Pharmaceutical Company based in Japan. Our Regulatory Science Team is instrumental in defining and executing regulatory strategies related to the development, registration, and market maintenance of gene therapies. This pivotal role within the Regulatory Science team will focus on the development of global regulatory strategies and the execution of regulatory activities for ex-vivo Gene Therapy (GT) assets. The primary focus will be on geographical expansion and post-approval lifecycle management of GT products in regions outside the United States, providing a unique opportunity to engage with groundbreaking science and a dedicated team. Key Responsibilities 1. Facilitate the registration of new marketing authorization applications (MAAs) and post-approval activities in designated “rest of the world (ROW)” regions (e.g., Middle East, Latin America, Asia Pacific) in collaboration with local partners:· Evaluate local guidelines and requirements for the registration of Advanced Therapy Medicinal Products (ATMPs) in targeted markets.· Develop and implement regulatory strategies to ensure a smooth path to approval.· Assist in the preparation of pre-MAA activities and the assembly of regulatory dossiers in line with business strategy.· Aid in preparing for health authority interactions, including drafting meeting requests and briefing materials.· Serve as the primary contact for local partners and coordinate cross-functional teams to prepare necessary submissions.· Coordinate and draft responses to inquiries and requests for information from regulatory authorities.· Support launch activities in selected markets and plan post-approval activities to maintain licenses for the assigned countries.2. Engage in cross-functional team meetings, providing pertinent regulatory updates:

Jan 29, 2026

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