Teams at Monte Rosa Therapeutics

Provides strategic GCP and GCLP quality oversight for preclinical and clinical programs. Responsibilities include vendor and investigator site oversight, SOP authorship, risk-based compliance programs, CAPA and quality event management, training, audits, regulatory submission review, inspection readiness, and cross-functional collaboration. Requires extensive pharmaceutical or biopharmaceutical experience, knowledge of global GCP regulations, and leadership in matrixed startup environments.

Coordinates regulatory workflows and prepares FDA and international regulatory submissions, license renewals, and annual registrations. Reviews and formats clinical, CMC, and non-clinical documentation; tracks timelines and budgets; researches regulatory requirements; supports product registration; and interacts with regulatory agencies. Requires extensive small-molecule CMC expertise, FDA filing experience, and strong project management, analytical, organizational, and communication skills.

Leads immunology and inflammation drug development programs from mid- to late-stage development through regulatory submission. Responsibilities include integrated planning, scenario modeling, risk mitigation, regulatory coordination, budget and resource oversight, executive communication, and cross-functional leadership across clinical, CMC, manufacturing, regulatory, biomarker, translational, and commercial teams.