Director, Regulatory Affairs

At Gilead, we’re creating a healthier world for all people. For more than 35 years, we’ve tackled diseases such as HIV, viral hepatitis, COVID-19 and cancer – working relentlessly to develop therapies that help improve lives and to ensure access to these therapies across the globe. We continue to fight against the world’s biggest health challenges, and our mission requires collaboration, determination and a relentless drive to make a difference. Every member of Gilead’s team plays a critical role in the discovery and development of life-changing scientific innovations. Our employees are our greatest asset as we work to achieve our bold ambitions, and we’re looking for the next wave of passionate and ambitious people ready to make a direct impact. We believe every employee deserves a great leader. People Leaders are the cornerstone to the employee experience at Gilead and Kite. As a people leader now or in the future, you are the key driver in evolving our culture and creating an environment where every employee feels included, developed and empowered to fulfil their aspirations. Join Gilead and help create possible, together. Job Description Regulatory Advertising and Promotion (RA Ad/Promo) is a core function within Gilead's Global Regulatory Affairs organization and acts as a critical strategic partner across cross-functional teams. RA Ad/Promo provides strategic regulatory guidance and input on Gilead's commercial and corporate communications, and plays a critical role ensuring that these activities are compliant with governing laws, regulations, and Gilead policies and procedures, while enabling the business to compliantly meet its goals and objectives. This group also represents Gilead's commercial activities to U.S. regulatory agencies. You will manage the commercial regulatory strategy and execution of such for multip

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

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 strategic Director, Clinical Affairs to lead the planning, execution, and oversight of clinical studies supporting the development, regulatory approval, reimbursement, and commercialization of Noctrix Health’s medical devices. This leader will be accountable for the successful delivery of clinical programs, ensuring studies are executed efficiently, compliantly, on schedule, and within budget while generating high-quality clinical evidence that supports regulatory and business objectives. The Director, Clinical Affairs will serve as a key cross-functional leader and liaison among Clinical Affairs, Clinical Research, Regulatory Affairs, Quality, Product Development, and external partners. This individual will provide leadership across clinical operations, including sponsor oversight, site management, CRO and vendor management, clinical data quality, study execution, and evidence generation. 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: Lead the planning, execution, and oversight of medical device clinical studies from study start-up through close-out Contribute to clinical development strategies supporting product development, regulatory submissions, reimburse

This is where your work makes a difference. At Baxter, we believe every person—regardless of who they are or where they are from—deserves a chance to live a healthy life. It was our founding belief in 1931 and continues to be our guiding principle. We are redefining healthcare delivery to make a greater impact today, tomorrow, and beyond. Our Baxter colleagues are united by our Mission to Save and Sustain Lives. Together, our community is driven by a culture of courage, trust, and collaboration. Every individual is empowered to take ownership and make a meaningful impact. We strive for efficient and effective operations, and we hold each other accountable for delivering exceptional results. Here, you will find more than just a job—you will find purpose and pride. Your Role at Baxter Baxter is seeking an experienced leader to oversee Product Stewardship and the execution of environmental and social product-related regulatory programs across the enterprise. This role is responsible for monitoring emerging regulations, assessing business applicability, establishing implementation roadmaps, and driving cross-functional execution to ensure compliance across Baxter's global portfolio. The leader will work closely with business segments, drive collaboration with other functions such as R&D, Regulatory Affairs, Quality, and Legal, and Operations teams to translate evolving requirements into practical and timely actions. Success in this role requires exceptional program management, organizational leadership, and execution capabilities. The individual must be skilled at coordinating complex initiatives across multiple stakeholders, driving accountability, and ensuring that Baxter remains ahead of regulatory requirements while proactively identifying opportunities to develop products and solutions that

We are seeking a dynamic professional well versed in the electric utility industry to join our team as Manager, Policy and Regulatory Affairs. The ideal candidate has distributed energy resources (DER) and demand-side management expertise, and experience collaborating with a broad spectrum of industry and government stakeholders. You have the ability to translate EnergyHub's product vision into a set of regulatory and policy objectives with the power to unlock new opportunities across our business units. You are both a big picture and analytical thinker who can turn complex device and DER program data into digestible comments and thought leadership for a diverse audience. You’re motivated to interface with a wide range of stakeholders in the industry and find middle ground amongst utilities, customers, and the distributed energy community. And, you never lose sight of high-priority state, federal, and agency initiatives and proceedings with the potential to impact EnergyHub’s growth. Besides a rock-solid work ethic and a strong team-oriented personality, we’re looking for a candidate that is creative, passionate, and has a desire to break new ground in a constantly shifting landscape. Main Responsibilities The Manager, Policy and Regulatory Affairs, will be an integral part of the Regulatory Affairs team, with the primary responsibilities of accelerating EnergyHub’s growth through legislative, regulatory, and other policy advocacy and providing intelligence to support clients and shape EnergyHub’s long-term business strategy. They will lead EnergyHub’s engagement in public utility commission proceedings and legislative sessions to help scale existing customer programs, and advocate for reforms that ultimately unlock the full value of demand flexibility. The Manager, Policy and Regulatory Affairs will report to the Director of Regulatory Affairs and will collaborate with teams across the company to ensure that our advocacy reflects all that EnergyHub has to offer. Sp

POSITION SUMMARY: Join Natera as the Director of Development for our Early Cancer Detection (ECD) In Vitro Diagnostic (IVD) products. You will take ownership of the development, verification, and validation of our early cancer detection (ECD) Next Generation Sequencing products from feasibility exit through regulatory submission and post-market support. Every test represents a real person, and you will lead a team of scientists and managers to execute the performance data packages supporting PMA submissions. You will serve as the technical subject matter expert in FDA interactions, partnering across functions to deliver design-controlled diagnostic products that directly impact patient care. PRIMARY RESPONSIBILITIES: Own the execution of the technical strategy and phase-gated process of of development, design verification, and validation studies for ECD IVD devices utilizing cfDNA, methylation and other potential analytes Ensure rigorous compliance with applicable FDA Class III (PMA) design and development requirements Take ownership of the analytical performance strategy (limit of blank/detection, precision, linearity, interference, stability) for ECD assays, partnering directly with Regulatory Affairs (RA), biostatistics, bioinformatics and research teams Contribute to the robust transfer of assays to the commercial laboratory and manufacturing in support of the design transfer and operations teams Partner with clinical and biostatistics leaders on statistical analysis plans required for approvable device performance claims in clinical intended-use populations Think team by partnering directly across bioinformatics, biostatistics, software engineering, clinical, regulatory, and commercial functions to align development efforts with business goals, and drive resourcing and go/no-go recommendations at phase gates Deliver the analytical performance data package supporting Class III PMA submissions, developing a comprehensive approval strategy with RA Serve as t