29 results for Regulatory Associate Jobs in Wilmington, MA, US

Senior Manager / Associate Director, Regulatory Strategy - CMCLocation: Boston, MA USAMonte Rosa Therapeutics is seeking a highly skilled and self-motivated regulatory professional to join our teams. This role will focus on oncology, immunology, and related therapeutic areas. The successful candidat...

Leads regulatory CMC responsibilities for assigned products, including the development and implementation of regulatory strategies, preparation and review of submission-ready CMC documents, ensuring compliance with regulatory requirements, and serving as the regulatory representative at meetings wit...

Position Summary: The Associate Director, Commercial Regulatory Affairs leads the review and approval of promotional and medical communications for assigned brands. The role involves interacting with regulatory bodies like the FDA, ensuring compliance with regulations, and guiding internal teams thr...

Madrigal is a biopharmaceutical company pursuing novel therapeutics for non-alcoholic steatohepatitis (NASH), also known as metabolic dysfunction associated steatohepatitis (MASH). Our first therapy, Rezdiffra (resmetirom), was granted accelerated approval by the U.S. Food and Drug Administration (F...

Company Overview:Dyne Therapeutics is discovering and advancing innovative life-transforming therapeutics for people living with genetically driven neuromuscular diseases. Leveraging the modularity of its FORCE™ platform, Dyne is developing targeted therapeutics that deliver to muscle and the centra...

Title: Regulatory Affairs AssociateReporting to: Regulatory Affairs ManagerLocation: Boston, Massachusetts, USAWe are seeking a highly motivated and results-driven Regulatory Affairs Associate to join our dynamic sales team at Venus AI. You are responsible for supporting global registrations and ens...

Supports development and management of a program for tracking and reporting on RA CMC processes. Collaborates across RA CMC for communication on compliance risks and metrics. Works cross-functionally to support global strategic initiatives related to regulatory compliance. Ensures RA CMC commitments...

Responsible for developing regulatory strategy and submission plans for clinical programs, overseeing the preparation and submission of regulatory documents, managing compliance with reporting requirements, and providing global regulatory guidance. Manages staff and vendors as needed and supports he...

Income Research + ManagementIncome Research + Management is a Boston-based, privately owned, fixed income asset management firm. IR+M delivers strong performance and consistent results through a rigorous, bottom-up security selection process and strives to provide best-in-class client service to our...