Director, RA Global Regulatory Strategy

Role: Lead global regulatory strategy for Neuroscience products, managing the regulatory lifecycle from development through post-approval. Responsibilities: develop and execute global strategies to secure and maintain market approvals, lead the Global Regulatory Product Team (GRPT), coordinate cross-functional teams on regulatory dossiers, mitigate risks, and ensure compliance with global regulations. Serve as primary interface with regulatory agencies and influence global policies; oversee regulatory submissions and responses. Qualifications: Bachelor's in life sciences; 7+ years regulatory experience in pharma, including drug development in US and preferably EU/Japan; 5+ years in strategic leadership roles. Preferred: advanced degrees, certifications, 10+ years in global regulatory activities, and experience with biologics or small molecules across multiple regions. HighValue: expertise in neuroscience therapeutics, global regulatory strategy, lifecycle management, and cross-regional submissions. Collaboration: interface with senior management, cross-functional stakeholders, and external agencies. WorkSetup: not specified; likely office-based or hybrid based on typical roles.