SUMMARY:

The Director/Sr. Director of Regulatory Affairs Global Regulatory Lead, Global Regulatory Strategy, is responsible for developing and implementing global strategies to secure and maintain market approval for product(s) globally (US, EMA, Japan, Australia, Canada). Leads the Global Regulatory Team . Serves as the primary regulatory interface with the product development team and supporting functions. Proactively anticipates and mitigates regulatory risks. Ensures compliance with global regulatory requirements. Demonstrates leadership behaviors to build a cohesive team environment. Must have a solid understanding of drug development, regulatory requirements, Develops and implements accelerated submission strategies.

• Leads the GRT to development of creative global strategies in line with applicable regulations to achieve business objectives for development and marketed products.
• Leads cross-functional stakeholders and regulatory professionals to ensure inclusion of appropriate and clear strategic messaging in the content of global regulatory dossiers and responses to regulatory Agency requests.
• Accountable for ensuring that corporate goals are met. Key internal leader and driver of regulatory policy and strategy for assigned products.
• Prepares and maintains regulatory risk assessment and mitigation strategy and communicates plan to relevant stakeholders.
• Acts independently and collaborates with the GRA Head. May participate in or lead regulatory and Company initiatives.
• Influences the development of regulations and guidance. Analyzes legislation, regulations, and guidance and provides analysis to the organization, with worldwide accountability for assigned products.
• Makes decisions regarding work processes or operational plans and schedules to achieve the program objectives as agreed with the senior management.

QUALIFICATION REQUIREMENTS:

• Advanced scientific degree (i.e., PhD, MD, PharmD) or master’s degree with at least 10 years of drug development experience. GRL experience in Oncology is a great plus.
• Preferred Experience: 10+ years’ experience in pharmaceutical regulatory activities, with experience as lead regulatory strategist in two or more major regions in addition to the US, such as EU or Japan. Strong global drug development foundation with business acumen.

• Leads the GRT to development of creative global strategies in line with applicable regulations to achieve business objectives for development and marketed products.
• Leads cross-functional stakeholders and regulatory professionals to ensure inclusion of appropriate and clear strategic messaging in the content of global regulatory dossiers and responses to regulatory Agency requests.
• Accountable for ensuring that corporate goals are met. Key internal leader and driver of regulatory policy and strategy for assigned products.
• Prepares and maintains regulatory risk assessment and mitigation strategy and communicates plan to relevant stakeholders.
• Acts independently and collaborates with the GRA Head. May participate in or lead regulatory and Company initiatives.
• Influences the development of regulations and guidance. Analyzes legislation, regulations, and guidance and provides analysis to the organization, with worldwide accountability for assigned products.
• Makes decisions regarding work processes or operational plans and schedules to achieve the program objectives as agreed with the senior management