Senior Manager, Global Regulatory Affairs, Marketed Products

Role: Senior Manager, Global Regulatory Affairs for Marketed Products, supporting regulatory submission processes and compliance for Takeda's global portfolio. Responsibilities: collaborate with regional leads and cross-functional teams to prepare and submit regulatory dossiers, manage ongoing regulatory activities for clinical trials, and ensure compliance with FDA, EMA, and other authorities; assist with health authority meetings and responses; conduct regulatory intelligence and competitor analysis; support regulatory document management systems and business development activities. Requirements: Bachelor's degree in Pharmacy, Pharmaceutical Science, Chemistry, Biology, or related field; 4+ years of experience in regulatory submissions to US FDA, EMA, and international authorities; experience with Fast Track and Orphan Drug designations, regulatory planning, and managing submissions such as INDs, CTAs, DSURs, and safety notifications; strong knowledge of clinical trial regulatory processes and cross-functional collaboration. High-value: experience with global regulatory strategy, regulatory intelligence, and compliance for marketed biopharma products; familiarity with clinical trial and post-market regulatory activities. Work setup: up to 75% remote; up to 30% domestic travel.