40 results for Regulatory Manager Jobs in Needham, MA, US

Drive global regulatory strategy for mast cell disease programs, oversee key regulatory submissions, collaborate with cross-functional teams, lead planning for health authority meetings, and provide guidance on regulatory requirements while ensuring compliance with evolving regulatory guidelines.

At WHOOP, we're on a mission to unlock human performance. WHOOP empowers members to perform at a higher level through a deeper understanding of their bodies and daily lives.WHOOP is seeking a Regulatory Affairs Manager (Medical Devices) to navigate and manage regulatory affairs for Medical Device So...

The Regulatory Compliance Manager at Dana-Farber is responsible for coordinating and leading regulatory compliance activities across all sites. This role is crucial in managing Dana-Farber’s regulatory readiness program and providing expertise on regulatory needs throughout the organization. The Reg...

About UsDianthus Therapeutics is a publicly traded, clinical-stage biotechnology company dedicated to designing and delivering novel, best-in-class monoclonal antibodies with improved selectivity and potency. Based in New York City and Waltham, Mass., Dianthus is comprised of an experienced team of ...

Responsible for coordinating regulatory compliance activities, managing regulatory readiness programs, and leading compliance initiatives across all sites. Duties include preparing for accreditation surveys, collaborating with external partners, analyzing regulatory requirements, and developing comp...

Regulatory Affairs Manager IIEST time preferred) - Maybe central, but not west coast.100% Remote (EST time zone)12 months+ResponsibilitiesPerforms eCTD submission management across Bi's product portfolio to Health Authorities for global development and lifecycle management submissions.The Regulatory...

Senior Manager Regulatory Affairs Hybrid - Cambridge We are seeking a Senior Manager RA to lead global regulatory submission activities across development programs. This strategic and hands-on role will be responsible for managing vendors and contributing to global RA strategy and ensuring timely, h...

An innovative oncology-focused biotechnology organization in the Boston area is seeking a Senior Manager, Regulatory Affairs CMC to support the development of its lead investigational program as it advances toward the clinic.This position will play a critical role in driving CMC regulatory strategy ...

Job DescriptionWe are seeking a Senior Manager in Regulatory, CMC who can independently lead, contribute and execute on CMC regulatory activities in support of Deciphera’s studies across all stages of clinical drug development. The primary responsibility will be to generate high quality and complian...

Lead and execute CMC regulatory activities for clinical drug development, generate compliant regulatory submissions, provide guidance on regulatory content, review documentation, communicate with regulatory Health Authorities, and ensure alignment with current regulations.