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

8+ years’ experience in the pharmaceutical or biotech industry, or within a health authority, with a focus on Regulatory Affairs and/or Pharmacovigilance
Strong understanding of EU and US regulatory and pharmacovigilance requirements across the drug development lifecycle
Experience sourcing, monitoring, and interpreting regulatory information from health authority platforms and other intelligence sources
Strong analytical skills, with the ability to identify key regulatory risks and implications
Clear, concise written and verbal communication skills
Strong organizational skills and attention to detail
A collaborative, practical approach to working across teams and functions

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)

Senior Manager, Regulatory Intelligence

Key skills