About this role
Associate Director, Regulatory Affairs CMC at Skyhawk Therapeutics. Location: Waltham, Massachusetts, United States. Role: supporting strategy, authoring content, coordinating responses Requirements: 7+ years Reg Affairs CMC pharmaceutical experience, hands-on CTD Module 3 authorship, familiarity with FDA/EMA/ICH guidance, experience with IND/NDA/MAA submissions, strong written and verbal communication. Category: Research and Development (R&D) Seniority: Senior Level Commitment: Full Time Workplace: Onsite Languages: English