Regulatory Intelligence Manager – FSP (Fully Remote, U.S.)
Job ID: R-01334925
Job Type: Full-Time
Category: Clinical Research
Work Model: Fully Remote
Preferred Location: U.S. East Coast
About the Role
Thermo Fisher Scientific is seeking an experienced Regulatory Intelligence Manager to support its Functional Service Partnership (FSP) division within the PPD clinical research portfolio. This fully remote role plays a strategic function in monitoring global regulatory developments and guiding internal stakeholders to ensure compliance, alignment, and informed decision-making across clinical and operational programs.
As part of a leading global contract research organization (CRO), this position contributes to advancing scientific innovation, improving operational readiness, and supporting the development of life-changing therapies.
Position Summary
The Regulatory Intelligence Manager will lead the identification, analysis, and communication of regulatory trends, policy changes, and emerging frameworks across major global health authorities. The role serves as a central strategic partner, ensuring cross-functional teams are informed, aligned, and prepared to respond to new regulatory expectations.
Key Responsibilities
Global Monitoring: Track regulatory updates, guidance documents, policy changes, and trends across agencies including FDA, EMA, PMDA, ICH, EU Commission, ISO, and others.
Impact Analysis: Evaluate the implications of regulatory changes on ongoing development programs, compliance practices, and operational activities.
Cross-Functional Collaboration: Partner with Regulatory Affairs, Clinical Operations, Quality, Pharmacovigilance, and Legal teams to ensure consistent awareness and alignment.
Regulatory Communication: Develop and distribute internal newsletters, alerts, and briefing documents tailored to relevant audiences. Manage publication of select content to internal communication platforms.
Precedent Research: Support regulatory precedent searches and contribute to drafting responses and evidence-based analyses.
Knowledge Management: Maintain a centralized, accessible repository of regulatory intelligence materials, tools, and references.
External Engagement: Participate in industry forums, working groups, and regulatory networks to anticipate emerging regulatory expectations and best practices.
Education and Experience Required
Bachelor’s degree in Life Sciences or a related field required; advanced degree preferred.
Minimum 5 years of specialized experience in regulatory intelligence within the biopharmaceutical or clinical research industry.
Strong understanding of global regulatory frameworks, drug development processes, and international guidance structures.
Proven expertise in analyzing complex regulatory information and translating insights into actionable recommendations.
Experience with regulatory intelligence tools such as Clarivate, Citeline, and industry databases.
Familiarity with and proficiency in generative AI technologies and applications.
Equivalent combinations of education, training, and directly relevant experience may be considered.
Skills and Competencies
Excellent analytical and critical-thinking skills.
Strong scientific writing, editing, and presentation capabilities with advanced command of English.
Ability to manage multiple priorities and deliver high-quality outputs in fast-paced environments.
Effective stakeholder management and ability to communicate complex information clearly.
Strong project management skills with the ability to handle multiple concurrent initiatives.
Work Environment
Fully remote role with standard Monday–Friday work schedule.
Work performed in a virtual office environment with extended periods of computer-based tasks.
Why Join Thermo Fisher Scientific
Thermo Fisher Scientific offers a collaborative and growth-driven environment where employees contribute to meaningful scientific impact. As part of a global workforce of more than 100,000 professionals, you will benefit from:
Competitive compensation and benefits
Opportunities for professional development
A culture built on Integrity, Intensity, Innovation, and Involvement
The ability to directly support scientific breakthroughs that improve global health
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