Lead development and execution of global regulatory strategy.
Act as a subject matter expert in regulatory affairs for product introduction.
Participate in quality system and design dossier audits.
Jobgether is a platform that helps candidates get jobs by using AI-powered matching process. They appear to be a medium-sized company that values speed, objectivity, and fairness in their application review process.
Provides regulatory guidance throughout the clinical development life cycle.
Develops and/or reviews documents intended for submission to the Regulatory Authorities and/or Ethics Committees to assure compliance with regulatory standards.
Keeps abreast and continually expands knowledge of laws, regulations and guidelines governing drug development and approval.
Precision Medicine Group is a company that works in the clinical trial space. They are an equal opportunity employer that values diversity and does not discriminate based on race, color, age, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status or other characteristics protected by law.
Be the RA representative on core functional teams for advertising and promotion and global software regulatory classification.
Work closely with SW development, engineering, architect, quality and cybersecurity teams.
Represent RA in the assessment of global cybersecurity and data privacy initiatives.
Dexcom Corporation is a pioneer and global leader in continuous glucose monitoring (CGM). They have broadened their vision beyond diabetes to empower people to take control of their health with personalized, actionable insights. Dexcom has thousands of ambitious, passionate people worldwide.
Author administrative and CMC regulatory documents in collaboration with SMEs.
Manage full CMC submissions, ensuring compliance with requirements.
Jobgether is a company that uses an AI-powered matching process assisting partner companies with their recruitment needs. They aim to ensure applications are reviewed quickly, objectively, and fairly.
Own the AI-Driven Roadmap: Define and manage the detailed product roadmaps for new AI products across X-ray, CT, MRI, and Ultrasound—from initial concept through launch sequencing and ongoing iteration.
Drive Modality Deployments: Lead end-to-end deployment of new AI products for each modality, coordinating cross-functional readiness across AI, clinical quality, clinical operations, data, and engineering.
Own Data Product Requirements: Partner closely with Data Engineering to define requirements for data quality, preprocessing pipelines, storage, and architecture that enable reliable model training and production performance.
Imagen Technologies is building the AI-enabled radiology practice of the future. They operate the first vertically integrated medical practice + AI development platform focused on reducing diagnostic error and giving radiologists superpowers through industry-leading AI solutions that they develop in-house.
Lead the company’s U.S. regulatory strategy for digital health, telemedicine, pharmacy, and consumer products.
Oversee all regulatory filings, submissions, and registrations, including FDA establishment registrations and product listings.
Provide regulatory intelligence—monitoring federal and other regulatory activity and synthesizing developments into clear, actionable insights for internal teams.
Hims & Hers is a health and wellness platform with a mission to improve health around the world. They are customer-centric, and focused on affordability, access, and personalized care. Hims & Hers is a public company traded on the NYSE under the ticker symbol “HIMS”.
Develop submission strategies and plans for post-approval CMC activities.
Assess change controls and provide regulatory assessments of quality changes.
Coordinate submission preparation with various departments.
Parexel is a leading global clinical research organization (CRO) providing insights-driven clinical and consulting solutions to the world’s life sciences industry. Leveraging deep local knowledge, they work in partnership with biopharmaceutical leaders, emerging innovators and sites.
Build and mature core elements of Rula’s enterprise Compliance Program.
Ensure adherence to federal and state healthcare regulatory requirements across Rula’s clinical operations.
Lead compliance risk assessments and internal controls; oversee investigations and corrective action processes.
Rula is dedicated to treating the whole person and aims to create a world where mental health is no longer stigmatized. Rula is a remote-first company that is passionate about making a positive impact on the lives of those struggling with mental health issues.
Critically review promotional and medical materials in compliance with corporate standards and government/industry regulations
Act as the Technical/QC Medical Reviewer by fact-checking all claims and performing detailed reference checking
Remain current on regulations and best practices within the industry
Nuvalent is dedicated to creating selective medicines to address the unmet needs of patients with cancer, leveraging their expertise in chemistry. As an early-stage entity, Nuvalent brings together seasoned scientists and industry experts with a strong history in oncology drug development, drug discovery, and company building.
Evaluate AI-generated content using your biological training.
Provide feedback to help AI better understand biological reasoning.
Work on a flexible, asynchronous schedule with no minimum hour requirement.
Handshake AI utilizes AI technology. They value expertise in biological reasoning, experimental design, data interpretation, and scientific problem-solving.
Acting as first point of contact for all inbound compliance queries, routing matters as necessary to appropriate team members and tracking completion
Supporting and coordinating recurring compliance tasks that help mitigate regulatory risk to the company
Assisting with preparation and submission of routing regulatory filings such as state registrations and annual reports
Virta Health is dedicated to reversing metabolic disease in one billion people through personalized nutrition and virtual care. They have raised over $350 million and partner with health plans, employers, and government organizations.
CentralReach is a leading provider of autism and IDD care software for Applied Behavior Analysis (ABA), multidisciplinary therapy, and special education. With over 200,000 users and backed by Roper Technologies, Inc., they are entering an exciting phase of growth and innovation.