Senior Manager Regulatory Affairs

Role: Senior Manager, Regulatory Affairs supporting clinical development and commercialization of drug-device combination products for pulmonary hypertension. Responsibilities: develop and execute global regulatory strategies, manage submissions (INDs, NDAs, amendments, lifecycle updates), coordinate with CROs, prepare responses to health authorities, support clinical trial regulatory compliance, and collaborate with cross-functional teams including Clinical Development, CMC, Safety, and Medical Affairs. Requirements: Bachelor's in life sciences or related field, 5+ years in regulatory affairs with experience managing international filings, especially in biotech or drug-device combos; familiarity with FDA, EMA, and global regulatory processes; knowledge of GxP, ISO, and MDR standards; 10-20% business travel. High-Value: focus on rare cardio-pulmonary indications, drug-device combination products, global regulatory submissions, experience with clinical trial support, and interactions with health authorities. Work setup: not specified, but involves cross-regional collaboration and external partner engagement.