Senior Director, Regulatory Intelligence jobs in United States
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Regeneron · 13 hours ago

Senior Director, Regulatory Intelligence

Regeneron is a leading biopharmaceutical company, and they are seeking a Senior Director of Regulatory Intelligence to lead global regulatory intelligence activities. The role involves providing direction and mentorship to a team, overseeing the delivery of regulatory information, and ensuring compliance with global regulations.

BiopharmaBiotechnologyPharmaceutical
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Comp. & Benefits
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H1B Sponsor Likelynote

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

Qualification

Regulatory affairs experienceRegulatory intelligence experienceBiopharmaceutical experienceAnalytical skillsRegulatory agenciesStrategic thinkingTeam leadershipMentorshipCross-functional collaboration

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
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

Benefits

Health and wellness programs (including medical, dental, vision, life, and disability insurance)
Fitness centers
401(k) company match
Family support benefits
Equity awards
Annual bonuses
Paid time off
Paid leaves (e.g., military and parental leave)

Company

Regeneron

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Regeneron Pharmaceuticals specializes in the discovery, development, and commercialization of innovative medicines.

H1B Sponsorship

Regeneron has a track record of offering H1B sponsorships. Please note that this does not guarantee sponsorship for this specific role. Below presents additional info for your reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (157)
2024 (128)
2023 (128)
2022 (137)
2021 (104)
2020 (122)

Funding

Current Stage
Public Company
Total Funding
$15.93M
Key Investors
U.S. Department of Health & Human Services
2024-07-11Post Ipo Equity· $2.03M
2023-10-18Post Ipo Equity· $5M
2016-08-22Post Ipo Equity· $8.9M

Leadership Team

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Aris Baras
Senior Vice President, Regeneron Pharmaceuticals, General Manager, Regeneron Genetics Center
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Bari Kowal
Senior Vice President, Head Development Operations & Portfolio Management
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Company data provided by crunchbase