Regulatory Affairs Jobs in United States

MISSION Mirum Pharmaceuticals is a biopharmaceutical company dedicated to transforming the treatment of rare diseases. We are passionate about advancing scientific discoveries to become important medicines for rare disease patients. We are collaborative, creative, and experienced professionals and w

Who are we? Arbor Biotechnologies, a clinical stage, next-generation gene editing company based in Cambridge, MA, is advancing a portfolio of first-in-class genomic medicines addressing serious diseases for which there are no existing functional cures, with a CNS pipeline initially prioritizing mult

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

Associate Director / Director, Regulatory Affairs About the Role We are seeking a highly skilled and experienced Associate Director / Director of Regulatory Affairs to join our growing clinical team. This hands-on position will be responsible for overseeing and managing global regulatory activities

Senior Director, Regulatory Affairs The Senior Director, Regulatory Affairs is responsible for planning, developing, and implementing regulatory strategy, submissions, and compliance activities for small molecule programs across early and late-stage development to support global regulatory approvals

Join the Mitsubishi Motors North America (MMNA) Team! At Mitsubishi Motors NA, we are driving innovation, quality, and excellence in the automotive industry. Our commitment to delivering cutting-edge vehicles goes hand in hand with our dedication to fostering a dynamic and inclusive wor

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

Our mission is to detect cancer early, when it can be cured. We are working to change the trajectory of cancer mortality and bring stakeholders together to adopt innovative, safe, and effective technologies that can transform cancer care. We are a healthcare company, pioneering new technologies to a

AskBio Inc., a wholly owned and independently operated subsidiary of Bayer AG, is a fully integrated gene therapy company dedicated to developing life-saving medicines and changing lives. The company maintains a portfolio of clinical programs across a range of neuromuscular, central nervous system,

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

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

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

Our mission is to detect cancer early, when it can be cured. We are working to change the trajectory of cancer mortality and bring stakeholders together to adopt innovative, safe, and effective technologies that can transform cancer care. We are a healthcare company, pioneering new technologies to a

Duties and Responsibilities Support Engineering and Product Development teams to successfully complete and obtain product registrations Determine the types of regulatory submissions or documentation required for projects with product design changes, manufacturing changes, or labeling changes Advise

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, y

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

Your work will change lives. Including your own. The Impact You’ll Make Recursion is at the forefront of reimagining drug discovery and development through broadening the funnel of potential targets, using technology and standardization to build connected data, and superlinearly scaling our ef

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

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 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