Senior Director, Regulatory Intelligence

Regeneron Pharmaceuticals • Rensselaer, NY

113d • $200,000 - $333,400

About The Position

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.

Requirements

• 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.
• 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 on matters related to Regeneron.

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.

Benefits

• Health and wellness programs
• Fitness centers
• Equity awards
• Annual bonuses
• Paid time off for eligible employees at all levels

What This Job Offers

• Job Type: Full-time
• Career Level: Senior
• Industry: Chemical Manufacturing
• Education Level: Bachelor's degree