Director, RA Global Regulatory Strategy

Role: Serve as Global Regulatory Lead (GRL II) for Neuroscience, developing and executing global regulatory strategies for assigned medicines throughout all development phases and post-approval, ensuring compliance and timely market access. Responsibilities: lead cross-functional teams (GRPT, LRST), craft strategic regulatory dossiers, mitigate risks, influence global regulations, and maintain alignment with senior management; mentor team members and contribute to regulatory policy development. Requirements: Bachelor's in life sciences; 7+ years in pharmaceutical regulatory affairs with experience in drug development and global strategy; strong cross-functional leadership, communication, and negotiation skills; proven track record in US&C or major regions like EU/Japan. Preferred: advanced degree, 10+ years' experience, regulatory leadership in multiple regions, and knowledge of neuroscience or neurodegenerative therapies. High-Value: focus on neuroscience therapeutics, extensive global regulatory strategy, lifecycle management, and influence on policy; experience with GxP, regulatory submissions, and agency interactions. Collaboration: interface with senior management, cross-functional teams, and industry groups. Work Setup: not specified; likely hybrid or remote based on location.