Senior Manager, Global Regulatory Affairs, Marketed Products

Senior Manager, Global Regulatory Affairs for Marketed Products, supporting regulatory submission processes and compliance for Takeda's global portfolio.

• collaborate with regional leads and cross-functional teams to prepare and submit regulatory dossiers
• manage ongoing regulatory activities for clinical trials
• 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

• 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

• experience with global regulatory strategy, regulatory intelligence, and compliance for marketed biopharma products
• familiarity with clinical trial and post-market regulatory activities

up to 75% remote; up to 30% domestic travel.