Senior Director, Regulatory Intelligence
New Yesterday
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.
A day in the life may look like:
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
This may be the right role for you if you have:
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
In Order to be considered qualified for this role you must have:
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.
- Location:
- Tarrytown
- Job Type:
- FullTime