Regulatory Affairs Jobs in United States

Company Overview Immunome is a clinical-stage targeted oncology company committed to developing first-in-class and best-in-class targeted cancer therapies. We are advancing an innovative portfolio of therapeutics, supported by a leadership team with deep experience in the design, development, and co

Attention recruitment agencies: All agency inquiries are vetted through 4DMT’s internal Talent Acquisition team. No unsolicited resumes will be accepted. The 4DMT Talent Acquisition team must expressly engage agencies on any requisition. Agencies contacting hiring managers directly will not be toler

Who Are We? Arbor Biotechnologies™, a next-generation gene editing company based in Cambridge, MA, is advancing a pipeline of novel gene editing therapeutics to address a wide range of genetic conditions – from the ultra-rare to the most common genetic diseases. The company’s unique suite of optimiz

More than one million people in the United States today are fighting blood cancer. While a traditional allogeneic stem cell transplant has been the best hope for many, the transplant itself can prove fatal or lead to serious conditions, such as graft vs. host disease. Orca Bio is a commercial-stage

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

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

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

Collegium Pharmaceutical is building a leading, diversified biopharmaceutical company committed to improving the lives of people living with serious medical conditions. We have a leading portfolio of responsible pain management and neuropsychiatry medications. Hybrid: Required to be onsite in Stough

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

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

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

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

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

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

Your work will change lives. Including your own. The Impact You’ll Make Lead development and implementation of CMC regulatory strategy for small molecule investigational drugs in global Phase 1-3 clinical trials and marketing applications. Influence the regulatory strategy of Recursion’s devel

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