Senior Director, Regulatory Intelligence

Role Summary

The Senior Director of Regulatory Intelligence will lead global regulatory intelligence activities and partner with other members of the Regulatory Intelligence Leadership Team to deliver a robust Regulatory Intelligence program. The responsibility of the Senior Director will primarily focus on providing direction, supervision, and mentorship to the Regulatory Intelligence sub-team that supports Industrial Operations and Product Supply (IOPS) and other strategic functions.

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

Qualifications

• Required: Must have a Bachelor's degree with 12 years of relevant biopharmaceutical experience, at least 8 years of hands-on regulatory affairs or regulatory intelligence experience
• Required: Balance of strategic thinking and strong analytical skills with ability to execute
• Required: Understanding of worldwide regulatory agencies, regulatory submissions and regulations
• Required: Understanding of available tools for identifying, cataloging and responding to regulatory publications on matters related to Regeneron
• Preferred: Ability to lead cross-functional teams in understanding regulatory changes and to provide feedback on proposed regulations, rules, and guidance
• Preferred: Experience in supporting business stakeholders in driving strategies for compliance with global regulatory requirements
• Preferred: Experience overseeing the review of regulatory information as it relates to the business and stakeholder requests
• Preferred: Ability to develop recommendations to draft rules and guidance documents by Health Authorities in collaboration with internal stakeholders
• Preferred: Experience liaising with Legal and Public Policy and Government Affairs to ensure consistency in interpretation and communication of regulatory information