Regeneron
SeniorManagerRegulatoryIntelligence
Neural analysis suggests this role is
optimal for Manager candidates.
“Senior Manager Regulatory Intelligence at Regeneron. Skills: Regulatory intelligence, Pharmacovigilance, Regulatory strategy, GxP compliance. Monitor regulatory guidance. Assess regulatory guidance”
Industry & Context.
Identify regulatory risks
What They're Looking For.
Must Have
8+ years experience pharma/biotech/health authority, Regulatory Affairs/Pharmacovigilance focus, EU and US regulatory requirements, Sourcing regulatory information, Interpreting regulatory information, Identifying regulatory risks, Clear written communication, Clear verbal communication, Organizational skills, Attention to detail
Nice to Have
Experience in regulatory affairs, Experience in pharmacovigilance
What You'll Do.
Monitor regulatory guidance
Assess regulatory guidance
Evaluate regulatory developments
Determine relevance of developments
Determine impact of developments
Prepare regulatory intelligence summaries
Prepare regulatory intelligence reports
Prepare regulatory intelligence presentations
Act as point of contact
Respond to ad-hoc requests
Identify business-critical changes
Communicate implications
Support regulatory commenting
Facilitate regulatory briefings
Facilitate regulatory meetings
Facilitate knowledge-sharing sessions
Maintain regulatory intelligence content
Improve intelligence capture
Improve intelligence sharing
How You'll Work.
Team & Collaboration
Cross-functional teams; Cross-functional stakeholders; Across teams; Across functions
Communication Scope
Written communication; Verbal communication; Concise communication
Full Job Description
We are seeking a Senior Manager, Regulatory Intelligence to play a key role in monitoring, interpreting, and communicating changes in the global regulatory landscape, with a strong focus on EU regulatory strategy and pharmacovigilance. In this role, we partner closely with cross‑functional teams to translate regulatory developments into clear, actionable insight that supports drug development, regulatory strategy, and GxP compliance across the organization. ## A Typical Day May Include * Monitoring and assessing new and emerging regulatory guidance, legislation, and policy from global health authorities and industry bodies. * Evaluating regulatory developments to determine relevance and impact on development programs, regulatory strategy, and internal processes. * Preparing concise regulatory intelligence summaries, reports, and presentations tailored to different stakeholder groups. * Acting as a point of contact for regulatory intelligence questions and ad‑hoc requests. * Identifying business‑critical regulatory changes and proactively communicating implications to cross‑functional stakeholders. * Supporting regulatory commenting activities, including review and drafting of submissions to health authorities and industry organizations. * Facilitating regulatory intelligence briefings, meetings, and knowledge‑sharing sessions. * Maintaining regulatory intelligence content and contributing to improvements in how intelligence is captured and shared. * Mentoring junior team members, as needed. ## This Role May Be For You If You * Enjoy staying ahead of regulatory change and applying it in a practical, business‑focused way. * Have strong experience in regulatory affairs and/or pharmacovigilance within pharma or biotech. * Are confident interpreting regulatory guidance and understanding its impact across the drug development lifecycle. * Are comfortable working cross‑functionally and engaging with a range of stakeholders. * Can work independently, manage competing priori
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