Regulatory Affairs Manager, FDA Submissions

Monte Rosa Therapeutics, Inc is seeking an experienced regulatory affairs professional in Boston, MA. Responsibilities include coordinating regulatory workflows, compiling submissions to the FDA, and providing ongoing support to project teams.

The ideal candidate holds a Bachelors/Masters in a scientific discipline with at least 8 years of relevant experience. Strong knowledge of CMC requirements and excellent organizational skills are essential. The position involves direct interaction with regulatory agencies and is critical to the success of regulatory initiatives.