Associate Director, Regulatory Strategy

Role: Associate Director of Regulatory Strategy leading regulatory planning and interactions for Scholar Rock's neuromuscular pipeline, including anti-myostatin therapies. Responsibilities: develop regulatory strategies, serve as US regulatory lead, manage agency interactions, oversee submission of key documents (IND, BLA, briefing packages), ensure compliance, and provide regulatory intelligence; support cross-functional activities and manage Clinicaltrials.gov disclosures. Requirements: Bachelor's in life sciences, 5+ years in biopharma regulatory affairs, proven experience with biologics (preferably monoclonal antibodies) and rare diseases, strong leadership, communication, and stakeholder management skills. HighValue: biologics, monoclonal antibodies, rare neuromuscular diseases, regulatory submissions, agency engagement, US-based, 10% domestic/international travel. WorkSetup: located in greater Boston area; hybrid work environment.