Regulatory Affairs Jobs in United States

Erasca is a clinical-stage precision oncology company focused on discovering, developing and commercializing medicines for the benefit of patients with cancer. Our programs take novel approaches to shutting down one of cancer’s most commonly mutated signaling cascades, the RAS/MAPK pathway, wh

Company: At Annexon Biosciences we are a biopharmaceutical company advancing a late-stage clinical platform of novel therapies for people living with devastating classical complement-mediated neuroinflammatory diseases of the body, brain, and eye. Our novel scientific approach targets upstrea

About Eko Health Eko builds AI and digital tools to enable every healthcare provider to more accurately detect heart and lung disease – the leading causes of death globally. Our FDA cleared, industry leading products are used by hundreds of thousands of clinicians on millions of patients around the

The Opportunity: We are looking for a motivated and strategic regulatory professional to join our growing regulatory team at Relay Tx. You will ​contribute to the development and execution of innovative regulatory strategies to support the advancement of our transformative pipeline. You

Associate Director, Regulatory Affairs CMC Skyhawk Therapeutics is seeking a hands-on, Associate Director, Regulatory Affairs CMC (RegCMC) to support the development and execution of the global RegCMC strategy for Skyhawk's small molecule pipeline. Working closely with the Director, RegCMC, you will

Lead regulatory activities for filing INDs, CTAs, and maintenance activities for open applications, including DSURs, IND/CTA amendments, and responses to requests for information/queries. Work effectively and collaboratively with internal and external stakeholders to manage clinical regulatory activ

Noema Pharma is a biotech company developing groundbreaking therapies to address the most disabling symptoms in orphan conditions of the brain and nervous system. Noema’s research and development is focused on understanding and meeting patient needs using our novel therapies. Tasks The Director of R

ABOUT HOUSING CALIFORNIA Since 1988, Housing California (Housing CA) has worked to create a California with homes, health, and prosperity for all in thriving, sustainable communities. We bring together a diverse, cross-sector network to prevent and end homelessness, increase the supply of safe, stab

Retro develops therapies for diseases driven by the biology of aging. We focus on cellular reprogramming and autophagy to rejuvenate cell and tissue function with the ultimate aim of adding 10 years to healthy human lifespan. We’re hiring an experienced new member of our Regulatory team who will own

The Senior Director, Global Regulatory Affairs will provide strategic regulatory leadership across Janux’s clinical-stage oncology pipeline, supporting programs from early development through registration. This individual will lead global regulatory strategy for one or more programs while influencin

Vir Biotechnology, Inc. is a clinical-stage biopharmaceutical company focused on powering the immune system to transform lives by discovering and developing medicines for serious infectious diseases and cancer. Its clinical-stage portfolio includes programs for chronic hepatitis delta and multiple P

Kriya is a biopharmaceutical company whose mission is to develop life-changing gene therapies for diseases affecting millions of patients around the world.We leverage our proprietary computational engine, in-house manufacturing infrastructure, and integrated design platform to engineer technologies

Position Summary: Are you a mission-driven attorney with a passion for administrative law and regulatory advocacy? Do you want to research and analyze cutting-edge statutory, administrative, and constitutional issues? If so, Democracy Forward Foundation ("Democracy Forward") is looking for a Staff A

About EnergyHub EnergyHub is a leading provider of distributed energy resource (DER) management solutions that help utilities unlock the full potential of virtual power plants (VPPs). By connecting and optimizing customer-owned devices like smart thermostats, EV chargers, and batteries. EnergyHub en

About Loyal Loyal is a clinical-stage veterinary medicine company developing longevity drugs for dogs. Our mission is to help dogs live longer, healthier lives. We're pioneering a new category of veterinary prescription drugs that proactively and preventatively target the underlying drivers of aging

Azurity Pharmaceuticals is a privately held, specialty pharmaceutical company that focuses on innovative products that meet the needs of underserved patients. As an industry leader in providing unique, accessible, and high-quality medications, Azurity leverages its integrated capabilities and vast p

Position Summary We are seeking an experienced Medical Writer / Regulatory Affairs Specialist to lead the preparation and maintenance of Clinical Evaluation Reports (CERs), Periodic Safety Update Reports (PSURs), and Summary of Safety and Clinical Performance (SSCPs) for our orthopedic device portfo

Azurity Pharmaceuticals is a privately held, specialty pharmaceutical company that focuses on innovative products that meet the needs of underserved patients. As an industry leader in providing unique, accessible, and high-quality medications, Azurity leverages its integrated capabilities and vast p

Calyxo, Inc. is a medical device company headquartered in Pleasanton, California, USA. The company was founded in 2016 to address the profound need for improved kidney stone treatment. Kidney stone disease is a common, painful condition that consumes vast amounts of healthcare resources each year. O

We're looking for an Associate Manager, International Legislative & Regulatory Affairs to join Spotify's Government Affairs team. This role can be based in Washington, DC or London, United Kingdom. The Government Affairs team monitors, analyzes, and advocates on the legislative and regulatory issues