Senior Director, Regulatory Intelligence

About This Role

Lead global regulatory intelligence activities for Regeneron, focusing on Industrial Operations and Product Supply (IOPS) and other strategic functions. Provide direction, supervision, and mentorship to a specialized sub-team, ensuring timely communication of regulatory requirements and impact analysis.

Responsibilities

• Lead and manage a regulatory intelligence sub-team(s) that supports specialized areas within the business
• Serve as a senior resource and advisor on regulatory requirements and changes that impact stakeholders
• Lead, develop, and mentor staff that are monitoring and communicating new, revised, or emerging regulatory requirements from a global to local level
• Oversee the delivery of succinct summaries on regulatory requirements and information that clearly communicates relevant implications, expectations and potential impact to business policies, process, and strategies
• Ensure timely delivery of regulatory intelligence information to stakeholders to enable them to make decisions, refine strategies, and manage potential compliance risks
• Lead cross-functional teams in the understanding of regulatory changes and identify opportunities for providing feedback on proposed regulations, rules, and guidance
• Support business stakeholders in driving strategies for compliance with global regulatory requirements
• Oversee the review of regulatory information as it relates to the business and stakeholder requests
• Develop recommendations to draft rules and guidance documents by Health Authorities regarding how they should be written or revised in collaboration with internal stakeholders
• Liaise with Legal and Public Policy and Government Affairs (PP&GA), as necessary, to ensure consistency in interpretation and communication of regulatory information

Requirements

• Bachelor's degree
• 12 years of relevant biopharmaceutical experience
• 8 years of hands-on regulatory affairs or regulatory intelligence experience
• Balance of strategic thinking and strong analytical skills with ability to execute
• Understanding of worldwide regulatory agencies, regulatory submissions and regulations
• Understanding of available tools for identifying, cataloging and responding to regulatory publications

Qualifications

• Bachelor's degree
• 12 years of relevant biopharmaceutical experience, with at least 8 years of hands-on regulatory affairs or regulatory intelligence experience

Benefits