Senior Director – Global Regulatory Affairs

• Establish and execute the US regulatory strategy and plan for assigned products
• Ensure local plans align with global regulatory strategy and Global Regulatory Plans
• Lead oversight of regulatory submissions, approvals, and labeling for assigned US products
• Prepare, review, and deliver INDs, NDAs, BLAs, supplements, and responses
• Lead and participate in FDA meetings and interactions
• Develop briefing documents and agency negotiation strategies
• Define scientific priorities and key deliverables for assigned programs
• Lead labeling strategy and negotiations with FDA under GRL direction
• Interpret evolving US regulatory guidelines and communicate impacts
• Ensure compliance with US regulations and internal quality systems
• Own regulatory activities for assigned marketed products and manage alliance/CRO relationships
• Guide promotional claims and strategy with Global Marketing and US Brand Teams
• Partner with the GRL on Global Regulatory Plan development and implementation
• Share regulatory intelligence, FDA feedback, and submission status
• Anticipate regulatory risks and propose mitigation strategies
• Participate in regulatory governance and information-sharing forums
• Propose process improvements and lead cross-functional regulatory projects
• Recruit, manage, train, develop, coach, and performance-manage direct reports
• Monitor resources and workload, motivate employees, and manage performance

Requirements

• Advanced scientific degree (PhD, MD, or PharmD) with at least 5 years of relevant industry-related experience in regulatory affairs and/or drug development, OR bachelor’s degree with at least 10 years of relevant industry-related experience
• Knowledge of local/regional regulatory procedures and practices
• Awareness of evolving regulatory reform initiatives preferred
• Knowledge of the integrated drug development process and regulatory/business strategies
• Ability to find solutions and alternatives through teamwork
• Ability to assess and manage risk in a highly regulated environment
• Strong written, spoken, and presentation communication
• Negotiation and influence skills
• Attention to detail
• 8 years of industry-related regulatory affairs and/or drug development experience preferred
• Ability to recruit, manage, train, develop, coach, and supervise a complementary team

Core Competencies

Demonstrates expertise in US regulatory strategy and compliance, with a strong focus on leading regulatory submissions and interactions with the FDA. Proven ability to manage teams, develop negotiation strategies, and ensure alignment with global regulatory plans.