Regulatory Affairs Jobs in the United States
Pearl
Salt Lake City, UT
Since 2019, our team has engineered FDA-cleared computer vision capabilities for interpretation of 2D and 3D dental imagery — industry-leading capabilities which clinicians, practice owners, labs and insurers use to elevate the efficiency, accuracy and consistency of dental care around the world. The Head of Regulatory Affairs will lead the regulatory strategy and operations to ensure compliance with all relevant regulatory requirements, specifically focusing on FDA and Medical Device Regulation (MDR) as applied to Software as a Medical Device (SaMD).
Pearl AI
Salt Lake City, UT
Since 2019, our team has engineered FDA-cleared computer vision capabilities for interpretation of 2D and 3D dental imagery — industry-leading capabilities which clinicians, practice owners, labs and insurers use to elevate the efficiency, accuracy and consistency of dental care around the world. The Head of Regulatory Affairs will lead the regulatory strategy and operations to ensure compliance with all relevant regulatory requirements, specifically focusing on FDA and Medical Device Regulation (MDR) as applied to Software as a Medical Device (SaMD).
Pulmonx Corporation
Redwood City, CA
The Zephyr Valve was granted breakthrough status and approved by the FDA in June 2018, because according to the FDA it “represents a breakthrough technology as the device offers bronchoscopic lung volume reduction without surgery and its associated risks. The Senior Regulatory Affairs Specialist will play a critical role in ensuring that the company’s medical devices comply with global regulations, focusing on managing submissions, audits, and postmarket obligations.
Pulmonx Corporation
San Diego, CA
Provide strategic regulatory guidance to cross-functional teams (e.g., R&D, clinical, operations, legal, marketing) to ensure regulatory requirements are met throughout the product lifecycle. Present regulatory risks, strategies, and potential product impacts to senior leadership, providing insight into business and regulatory decision-making.
Pulmonx Corporation
Los Angeles, CA
Provide strategic regulatory guidance to cross-functional teams (e.g., R&D, clinical, operations, legal, marketing) to ensure regulatory requirements are met throughout the product lifecycle. Present regulatory risks, strategies, and potential product impacts to senior leadership, providing insight into business and regulatory decision-making.
Pulmonx Corporation
San Jose, CA
Provide strategic regulatory guidance to cross-functional teams (e.g., R&D, clinical, operations, legal, marketing) to ensure regulatory requirements are met throughout the product lifecycle. Present regulatory risks, strategies, and potential product impacts to senior leadership, providing insight into business and regulatory decision-making.
Pulmonx Corporation
Redwood City, CA
Provide strategic regulatory guidance to cross-functional teams (e.g., R&D, clinical, operations, legal, marketing) to ensure regulatory requirements are met throughout the product lifecycle. Present regulatory risks, strategies, and potential product impacts to senior leadership, providing insight into business and regulatory decision-making.
Tbwa Chiat/Day Inc
San Francisco, CA
We are seeking a detail-oriented Regulatory Affairs Coordinator to support our 2025 Compliance Roadmap by assisting with regulatory submissions, technical communications and documentation and information management for compliance (e.g., regulatory, legal, third party). Maintain, track, and complete technical documentation, including specifications, allergen statements, nutrition facts, safety data sheets, and percent range formulas, as required by customers.
Tbwa Chiat/Day Inc
San Francisco, CA
We are seeking a detail-oriented Regulatory Affairs Associate to support our 2025 Compliance Roadmap by assisting with regulatory submissions, technical communications and documentation and information management for compliance (e.g., regulatory, legal, third party). We want our workplace to enable productivity and meaningful work for individuals from all backgrounds, experiences, and lifestyles, allowing all employees to feel comfortable being their true, authentic selves at work.
Tbwa Chiat/Day Inc
Cambridge, MA
Regulatory strategy & executionPlay a core role in project teams, developing global regulatory strategies for drug development programs, including clinical and pre-clinical stage programs. MOMA Therapeutics is a clinical-stage, next-generation precision medicine company dedicated to targeting highly dynamic proteins that underlie human disease via a small molecule approach, utilizing its proprietary KNOMATICTM platform.
Tbwa Chiat/Day Inc
San Francisco, CA
Coordinate the authoring and timely submission of regulatory dossiers as required to support global clinical trial applications, including initial INDs/IND amendments, IMPDs, annual reports, requests for information, etc. Support interactions with global regulatory authorities to ensure acceptance of CMC information in support of regulatory submissions and applications, including leading the authoring of CMC content in briefing documents.
Tbwa Chiat/Day Inc
South San Francisco, CA
Bexotegrast has received Fast Track Designation and Orphan Drug Designation from the U.S. Food and Drug Administration for both idiopathic pulmonary fibrosis (IPF) and primary sclerosing cholangitis (PSC) and Orphan Drug Designation from the European Medicines Agency in IPF and PSC. Coordinate the authoring and timely submission of regulatory dossiers as required to support global clinical trial applications, including initial INDs/IND amendments, IMPDs, annual reports, requests for information, etc.
Tbwa Chiat/Day Inc
San Francisco, CA
Lead the development, revision, review, approval, and maintenance of primary labeling (the Company Core Data Sheet (CCDS), United States Package Insert (USPI) and associated patient labeling, EU Product Information (EUPI)), and derived documents (labeling text for EU, US) for assigned compounds. Bexotegrast has received Fast Track Designation and Orphan Drug Designation from the U.S. Food and Drug Administration for both idiopathic pulmonary fibrosis (IPF) and primary sclerosing cholangitis (PSC) and Orphan Drug Designation from the European Medicines Agency in IPF and PSC.
Tbwa Chiat/Day Inc
Bothell, WA
Our most advanced pipeline programs are varegacestat (formerly AL102), a gamma secretase inhibitor which is currently in a Phase 3 trial for treatment of desmoid tumors, IM-1021, a ROR1 ADC with an active IND, and IM-3050, a FAP-targeted radioligand, which is the subject of an IND expected to be submitted in the first quarter of 2025. We are advancing an innovative portfolio of therapeutics, drawing on leadership that previously played key roles in the design, development, and commercialization of cutting-edge targeted cancer therapies, including antibody-drug conjugate therapies (ADCs.)
Tbwa Chiat/Day Inc
Not Available, MA
Manage global regulatory lifecycle of assigned investigational products, including maintaining project timelines, organizing submission content, and coordinating the internal/external authoring and review of components of original investigational drug applications, amendments, and safety and annual reports. The incumbent will be responsible for contributing to and implementing regulatory strategies and plans to expedite global product development, managing regulatory communications/interactions with health authorities, and ensuring compliance with applicable regional regulations.
Tbwa Chiat/Day Inc
Pleasanton, CA
The ideal candidate will be based in the San Francisco Bay Area, have deep expertise in U.S. medical device clearance and approval processes, a strong background in reviewing marketing claims, and a solutions-oriented approach to partnering with product development, quality, marketing, clinical, and other key stakeholders. Act as a strategic partner to product development teams, providing regulatory guidance and input from the product concept phase through to product launch, ensuring products are designed and developed with regulatory compliance in mind.
Tbwa Chiat/Day Inc
San Mateo, CA
Today, we’re recognized as a global leader in entertainment producing The PlayStation family of products and services including PlayStation5, PlayStation4, PlayStationVR, PlayStationPlus, acclaimed PlayStation software titles from PlayStation Studios, and more. As Corporate Counsel, you’ll work closely with teams across our global business, including Product Safety & Compliance, ESG and Service and Business Operations, to establish processes and compliance programs to support the Product Regulatory and ESG functions across the full scope of PlayStation products and services.
Tbwa Chiat/Day Inc
Washington, DC
Weber Shandwick is seeking an Account Director to join its Public Affairs team to lead strategy and manage account teams supporting corporate, public sector, and non-profit clients navigating the intersection of business, politics, policy, and political culture. Where an employee or prospective employee is paid within this range will depend on, among other factors, actual ranges for current/former employees in the subject position; market considerations; budgetary considerations; tenure and standing with the company (applicable to current employees); as well as the employee’s/applicant’s background, pertinent experience, and qualifications.