Senior Strategist - Regulatory Affairs (CMC)

About Tr1X Tr1X is a clinical-stage biotechnology company developing engineered Tr1 cell therapies to restore immune balance in autoimmune and inflammatory diseases. Leveraging the unique biology of Tr1 cells, the company is advancing a pipeline of off-the-shelf allogeneic and in vivo CAR-Tr1 therapies designed to deliver targeted immunoregulation and address diseases driven by immune dysfunction, including transplant-related complications. Founded by pioneers in the discovery of Tr1 cells, Tr1X, Inc. is focused on developing durable, potentially curative therapies for conditions with high unmet need. For more information, visit www.tr1x.bio. Position Summary The Director, Medical and Regulatory Writing reports to the Vice President, Head of Regulatory Affairs and provides strategic planning, development, review, and delivery of high-quality medical, clinical, and regulatory documentation supporting Tr1X clinical programs. The role is responsible for establishing and executing medical writing strategies across clinical development programs, ensuring the timely preparation of scientifically accurate, regulatory-compliant documentation. The Director drives document quality and operational excellence and collaborates with senior leaders across Clinical Development, Regulatory Affairs, Biostatistics, Clinical Operations, Translational Medicine, CMC/Technical Operations, and other functions. The position plays a critical role in supporting regulatory milestones and submissions throughout the product lifecycle, while ensuring alignment with applicable regulatory requirements, scientific standards, and corporate objectives. Key Responsibilities Partner with Regulatory to develop and implement the medical writing strategy in alignment with corporate objectives, clinical development plans, regulatory strategies, and program goals. Author (writes & edits) high-quality documents across all program areas as needed such as clinical study protocols, protocol ame

Responsibilities: Supports UK, Ireland, Malta, Sweden, Finland, Norway, and Denmark products across the product portfolio. Supports the team with regulatory strategies (local and regional) that are in line with the business plan Supports the team with regulatory activities for National and/or European procedures (Decentralized, Mutual Recognition) as appropriate. For example, but not limited to: Prepares and compiles regulatory submissions, response to questions, renewals, post submission/approval activities (including relevant updates to external websites such as emc, medicines.ie and In-Demand) Supports ad hoc projects (e.g., compliance reviews, audit preparation etc.) Signs off on packaging material, leaflets, and SmPCs (as appropriate) Supports the compilation of the Northern Cluster team metrics for the EMEA biannual metrics report Supports all regulatory activities in Malta Ensures regulatory compliance within the department to include: The maintenance of global, regional, and local databases Adherence to processes, SOPs, work instructions, and job aids Updates to relevant local and global databases to track current product information Supports team with Calls for Information (CFI) and assist in any Pharmacovigilance- related activities within the Northern Cluster, which may include: Receiving and monitoring responses to CFIs through liaison with UK and EAME colleagues Ensuring responses are submitted in a timely manner and that they are in line with standard procedures and metrics established by the VP Regulatory Affairs in European Regulatory Provide support and responses to ad hoc requests received from UK PV group or Global Reg Med Mailbox Supports the team with regulatory activities for National and/or European procedures (Decentralized, Mutual Recognition) as appropriate. Ensures regulatory compliance within the department Experience/Qualifications: Bachelor's/Master's degree in Life Science/Pharma Minimum of 5 ~ 8 years of relevant work experience worki

Noctrix Health is redefining the treatment of chronic neurological disorders with clinically validated therapeutic wearables. Our team of medical device specialists, neuroscientists, and consumer electronics engineers is dedicated to delivering prescription-grade therapy with an outstanding user experience. We have pioneered the world’s first drug-free wearable therapy, clinically proven to alleviate symptoms in adults with drug-resistant Restless Legs Syndrome (RLS). Join us in transforming healthcare, improving lives, and driving meaningful change through innovative medical technology. We are seeking an experienced and highly organized Manager, Regulatory Affairs to lead and execute regulatory activities supporting the development, registration, commercialization, and post-market compliance of Noctrix Health’s medical devices. This role will help ensure regulatory strategies and deliverables are executed accurately, compliantly, and on schedule throughout the product lifecycle. The Manager, Regulatory Affairs will work closely with Clinical Affairs, Quality, Engineering, Operations, Marketing, and external regulatory partners to provide regulatory guidance, manage submissions, assess product changes, maintain global registrations, and support post-market regulatory activities. The ideal candidate combines strong medical device regulatory expertise with excellent project management skills and the ability to independently drive complex regulatory initiatives across multiple functions. This position reports to the Senior Vice President, Clinical & Regulatory Affairs . This is a full-time, hybrid position that is located at our Pleasanton headquarters. Responsibilities: Provide regulatory guidance to cross-functional teams supporting new product development, design changes, risk management, commercialization, and product lifecycle activities Perform and maintain regulatory assessments for product modifications, soft

Neptune Medical, is an innovative, venture capital funded medical device startup headquartered in Burlingame, CA. We have already commercialized novel medical devices using our technology. Now the team at Neptune is building something truly unique: a fully flexible medical robot that enables doctors to reach deep into human anatomy. Triton Robotic Endoscopy will disrupt flexible endoscopy and set a new standard in outcomes for decades to come. TITLE: Senior Manager of Clinical Affairs POSITION SUMMARY: The Clinical Affairs Senior Manager/Associate Director will be responsible for the design, execution and monitoring of clinical studies and will provide scientific expertise throughout the development and implementation of the studies. This role is accountable for the end-to-end clinical strategy, design, execution, oversight, and reporting of clinical studies supporting product development, regulatory submissions, and commercialization. S/he will work closely with R&D, Regulatory Affairs, Quality and external stakeholders to ensure high-quality, compliant, and efficient clinical programs and interact with regulatory agencies as needed to support regulatory submissions and audits. The ideal candidate would act with passion and intensity in a medical device start-up that is fast paced and collaborative and display the ability to perform to the requirements outlined below. For the right person, this position will be a tremendously exciting and career-defining opportunity, offering the opportunity to shape clinical strategy for a novel medical robotic platform and to contribute meaningfully to the company’s long-term success. ROLES AND RESPONSIBILITIES: Clinical Strategy and Leadership Lead the development and execution of the overall clinical strategy aligned with company and regulatory objectives. Provide expert input into clinical development plans, trial design, and evidence-generation strategies across the product lifecycle. Advise senior leadership

Atlas HXM is the global workforce platform built on compliance. We help companies determine how to engage each member of their workforce and then execute with accountability built in — direct Employer of Record (EOR), Agent of Record (AOR), payroll, and compliance capabilities backed by a decade of practitioner-led expertise. Recognized as a category Leader by NelsonHall and Everest Group, Atlas HXM builds Human Experience Management into everything we do, guided by our "For People, by People" principle. The future of work is borderless, and so are we. Our people are located around the globe — in the U.S., the UK, India, Colombia, China, and beyond. Diversity and belonging are not just values; they are who we are. We are also committed to making a positive impact. Through our Environment, Social, and Governance (ESG) impact initiative, we are addressing our environmental footprint and promoting social responsibility. Our impact program is central to our vision and culture, focusing on employee wellness, diversity, charitable work, and ethical corporate governance. The Senior Regulatory Affairs & Entity Corporate Governance Manager will lead the company’s regulatory strategy, ensuring compliance with all relevant regulations. This senior role focuses on managing regulatory affairs for the organization and providing strategic guidance on governance matters to support our corporate entities globally. The Senior Regulatory Affairs & Entity Corporate Governance Manager will work closely with legal, risk & compliance, and operational teams to implement a regulatory framework that meets both local and international requirements while fostering best practices in corporate governance. This is a 10-month fixed-term contract for an individual contributor. Key Responsibilities Regulatory Strategy Develop and execute a comprehensive regulatory strategy that aligns with the company's business objectives and supports its global operations. Monitor and interp

Atlas HXM is the global workforce platform built on compliance. We help companies determine how to engage each member of their workforce and then execute with accountability built in — direct Employer of Record (EOR), Agent of Record (AOR), payroll, and compliance capabilities backed by a decade of practitioner-led expertise. Recognized as a category Leader by NelsonHall and Everest Group, Atlas HXM builds Human Experience Management into everything we do, guided by our "For People, by People" principle. The future of work is borderless, and so are we. Our people are located around the globe — in the U.S., the UK, India, Colombia, China, and beyond. Diversity and belonging are not just values; they are who we are. We are also committed to making a positive impact. Through our Environment, Social, and Governance (ESG) impact initiative, we are addressing our environmental footprint and promoting social responsibility. Our impact program is central to our vision and culture, focusing on employee wellness, diversity, charitable work, and ethical corporate governance. Head of Global Regulatory Affairs and Entity Corporate Governance (12-month fixed-term maternity cover) The Head of Global Regulatory Affairs and Entity Corporate Governance will lead the company’s regulatory strategy, ensuring compliance with all relevant regulations. This senior role focuses on managing regulatory affairs for the organization and providing strategic guidance on governance matters to support our corporate entities globally. The Head of Global Regulatory Affairs and Entity Corporate Governance will work closely with legal, risk & compliance, and operational teams to implement a regulatory framework that meets both local and international requirements while fostering best practices in corporate governance. This is a 12-month fixed-term contract for an individual contributor. Key Responsibilities 1. Regulatory Strategy Develop and execute a comprehensive regulatory strategy that al