Director, RA Global Regulatory Strategy

Role: Lead global regulatory strategy for assigned therapeutic products, overseeing development and maintenance of regulatory dossiers and ensuring compliance across development stages. Responsibilities: develop and execute global regulatory plans, lead the Regulatory Product Team, interface with cross-functional stakeholders, mitigate regulatory risks, and influence regulatory policies. Manage products through all phases of development and post-market lifecycle, guiding strategic messaging and regulatory interactions. Qualifications: Bachelor's in life sciences; 7+ years regulatory experience, including drug development in US & C regions; 5+ years in strategic leadership with project management skills; experience with global regulatory strategies, dossier preparation, and stakeholder engagement. Preferred: advanced degree, 10+ years’ regulatory experience, and global product strategy experience in major regions like EU or Japan. High-Value: focus on pharmaceutical or biologic products, with responsibilities spanning pre-approval to post-market; strong emphasis on global regulatory compliance, lifecycle management, and cross-functional leadership. Work setup: not specified; global/regional scope.