Senior Director, Regulatory Intelligence
Scorpion Therapeutics, Troy, New York, United States
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
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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
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