Associate Director, Regulatory Affairs CMC and Devices

This position is posted by Jobgether on behalf of a partner company. We are currently looking for an Associate Director, Regulatory Affairs CMC and Devices in United States.

This role is a key regulatory leadership position within a clinical-stage biotechnology environment focused on advancing innovative biologic therapies for complex immune-mediated diseases. The Associate Director, Regulatory Affairs CMC and Devices is responsible for driving the preparation, coordination, and execution of global CMC regulatory submissions that support clinical development programs across multiple assets. You will play a critical role in ensuring compliance with evolving global regulatory expectations while enabling timely progression of clinical trials. This position requires close collaboration with technical operations, quality, and cross-functional regulatory teams, as well as external partners, to deliver high-quality, submission-ready documentation. You will also contribute to shaping regulatory strategies for drug-device combination products and supporting interactions with global health authorities. Operating in a fast-paced, science-driven environment, this role demands both deep technical expertise and strong cross-functional coordination skills to ensure regulatory excellence across multiple programs.