Regulatory Affairs Jobs

At Element Biosciences, we are passionate about our mission to empower the scientific community with more freedom and flexibility to accelerate our collective impact on humanity. We have built a highly efficient product-driven organization where employees can learn, grow, and thrive in a challenging

We are seeking a dynamic professional well versed in the electric utility industry to join our team as Manager, Policy and Regulatory Affairs. The ideal candidate has distributed energy resources (DER) and demand-side management expertise, and experience collaborating with a broad spectrum of indust

Fate Therapeutics is looking for Senior Manager, Regulatory Affairs CMC to help advance innovative cell therapy products from early development through licensure. In this role, you will shape global CMC regulatory strategy, lead high-quality submissions, partner across technical and quality teams, a

Drug development shouldn’t be guesswork, not when patients are waiting. Pathos is building a next-generation biotech with AI at the core. Not as a feature, but as the operating system for how medicines get developed. We believe most drugs don’t fail because the science was wrong. They fail because t

Market America a Global Product Brokerage and Internet Marketing company that specializes in One-to-One Marketing, is seeking a Director of Quality Control & Regulatory Affairs. The Director of Quality Control will manage the overall operations of the Quality and Regulatory Department to ensure that

Manager, Scientific & Regulatory Affairs | United States, Full-Time Manus works across industries and value chains to accelerate the transition to BioAlternatives – better performing and more sustainable versions of complex molecules traditionally sourced from plants, animals, or fossil fuels. Our p

Job Summary The Regulatory Affairs Strategist is responsible for developing and executing regulatory strategies that support the approval and lifecycle management of pharmaceutical products. This role serves as a key liaison between the company and regulatory agencies, ensuring compliance with appli

Prepare, review, and maintain regulatory submissions and documentation in compliance with applicable regulatory guidelines. Coordinate preparation of dossiers, variations, renewals, amendments, and other regulatory submissions. Review product documentation, specifications, analytical data, stability

We’re looking for purpose-driven, passionate individuals to join our team. From clinical to commercial to supporting functions, Lexitans believe in the common mission: to be the best ophthalmic product development organization to partner with. Lexitas is searching for a Fractional Director of Regula

Description Encoded Therapeutics Inc. is a biotechnology company advancing precision medicines for a broad range of genetic disorders. Our mission is to unlock new opportunities for viral gene therapy through genomics-driven discovery. We focus on delivering life-changing advances for individuals wi

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 Manager, Regulatory Affairs & Compliance, is a cross-functional role responsible for helping Traditional Medicinals scale responsibly within an increasingly complex regulatory, certification, and compliance environment. The role serves as the functional leader for Regulatory Affairs and C

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

Overview Monte Rosa Therapeutics is seeking a highly skilled and self-motivated regulatory professional to join our team as an Associate Director of CMC Regulatory Affairs. The CMC Regulatory Affairs will serve as a key regulatory strategist and author for the Chemistry, Manufacturing, and Controls

We are seeking a hands-on Manager, Quality Assurance & Regulatory Affairs (QA/RA) to lead our Quality and Regulatory function and own the systems that ensure our products and operations meet applicable quality and regulatory requirements. This is an opportunity for someone who is ready to take meani

Overview Responsible for the day-to-day leadership and operational management of the Regulatory Affairs function. This role oversees Regulatory Affairs personnel and ensures effective execution of U.S. and international regulatory activities, including regulatory submissions, inspections and audits,

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

Xcimer Energy leverages decades of research on Inertial Fusion Energy (IFE) combined with groundbreaking new laser architecture. Our mission is to deploy fusion power plants to meet global decarbonization goals as fast as possible. Xcimer has assembled a team of leaders in tough tech, fusion science

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