Regulatory Intelligence Manager – Fully Remote (FSP)
Locations: Remote, East Coast Preferred
Job Type: Full-Time | Clinical Research | Fully Remote
Job ID: R-01334925
About the Company
Thermo Fisher Scientific is a global leader in serving science, driving innovation in laboratory, digital, and decentralized clinical trial services. With clinical research conducted across 100+ countries, we empower biopharmaceutical organizations to develop life-changing therapies. Join a team dedicated to improving patient outcomes through excellence in research, regulatory compliance, and data-driven insights.
Role Overview
We are seeking a Regulatory Intelligence Manager to join our FSP (Functional Service Provider) team. This role is critical for monitoring, analyzing, and communicating global regulatory developments that impact the client’s drug development pipeline and operations. You will act as a strategic partner to cross-functional teams, providing actionable insights that guide regulatory strategy, compliance, and operational decision-making.
Key Responsibilities
Regulatory Monitoring & Analysis: Track global regulatory updates, guidance documents, and policy trends across key agencies (FDA, EMA, PMDA) and international stakeholders (EU Commission, ICH, ISO).
Impact Assessment: Collaborate with internal teams to evaluate the implications of regulatory changes on clinical development programs and operational practices.
Stakeholder Engagement: Work closely with Regulatory Affairs, Clinical, Quality, Pharmacovigilance, and Legal teams to align priorities and disseminate insights.
Communication & Reporting: Create and distribute internal newsletters, alerts, briefing documents, and publish selected content to internal knowledge-sharing platforms.
Precedent Research: Support research and draft responses to precedent search requests from internal and external stakeholders.
Knowledge Management: Maintain a centralized repository of regulatory intelligence resources for accessibility across teams.
External Representation: Engage with industry forums, working groups, and regulatory networks to remain at the forefront of regulatory trends.
Qualifications & Skills
Bachelor’s degree in Life Sciences or related field; advanced degree preferred.
Experience: Minimum 5+ years in regulatory intelligence or regulatory affairs within the biopharmaceutical or clinical research industry.
Strong knowledge of global regulatory frameworks, drug development lifecycle, and regulatory strategy alignment.
Exceptional analytical, writing, and presentation skills with perfect command of English.
Proven ability to translate complex regulatory information into actionable business insights.
Strong project management skills, with experience managing multiple priorities and deadlines.
Proficiency with regulatory intelligence tools and databases (e.g., Clarivate, Citeline) and familiarity with generative AI applications for regulatory analysis.
Why Join Us
Fully remote work with East Coast preference for optimal collaboration.
Collaborate with global biopharmaceutical teams to influence regulatory strategy and operational excellence.
Access to cutting-edge regulatory intelligence tools and AI-enabled workflows.
Be part of a global organization committed to improving patient outcomes, innovation, and compliance.
Thermo Fisher Scientific fosters a diverse and inclusive environment where all employees are valued. Join a team that thrives on Integrity, Innovation, Intensity, and Involvement.
Apply Today – Contribute to global regulatory excellence and accelerate drug development that transforms lives.
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