Regulatory Intelligence Manager – FSP (Fully Remote, US)
Job ID: R-01334925
Location: United States (Fully Remote; East Coast Preferred)
Job Type: Full-Time
Category: Clinical Research
About the Role
The Regulatory Intelligence Manager will serve as a strategic leader within Thermo Fisher Scientific’s PPD® clinical research portfolio, providing expert guidance on global regulatory developments. This role is critical in monitoring, analyzing, and communicating regulatory updates that impact drug development pipelines, ensuring that cross-functional teams are informed and aligned with evolving requirements.
As a part of a global CRO operating in over 100 countries, this role supports innovative clinical trials and decentralized research frameworks, enabling the development of life-changing therapies.
Key Responsibilities
Regulatory Monitoring & Analysis: Track global regulatory changes, guidance documents, policy updates, and trends across key markets including FDA, EMA, PMDA, and international agencies (EU Commission, ICH, ISO).
Impact Assessment: Evaluate the potential implications of regulatory updates on the client’s clinical development programs, operational practices, and compliance requirements.
Stakeholder Alignment: Collaborate closely with Regulatory Affairs, Clinical, Quality, Pharmacovigilance, and Legal teams to ensure awareness and proactive management of emerging regulatory risks.
Communication & Reporting: Develop and disseminate internal newsletters, alerts, and briefing documents; contribute to internal knowledge platforms for efficient regulatory intelligence sharing.
Precedent Research: Conduct and support regulatory precedent searches and draft informed responses for internal stakeholders.
Knowledge Management: Maintain a centralized repository of regulatory intelligence resources, ensuring accessibility and usability across teams.
External Engagement: Participate in industry forums, working groups, and regulatory networks to identify emerging trends and best practices.
Qualifications and Experience
Bachelor’s degree in Life Sciences, Pharmacy, or a related field; advanced degree preferred.
Minimum 5+ years of experience in regulatory intelligence or regulatory affairs within the biopharmaceutical industry.
Strong understanding of global regulatory frameworks, drug development lifecycle, and clinical trial requirements.
Proven ability to translate complex regulatory information into actionable insights for operational teams.
Excellent analytical, writing, and presentation skills; fluency in English is mandatory.
Experience with regulatory intelligence platforms (e.g., Clarivate, Citeline) and familiarity with generative AI applications in regulatory workflows.
Strong project management, prioritization, and cross-functional collaboration skills.
Equivalency: In certain cases, a combination of education, training, and relevant experience may satisfy the role requirements.
Why Join Thermo Fisher Scientific / PPD?
Thermo Fisher Scientific empowers teams to accelerate research, develop innovative therapies, and deliver measurable impact on global health. Benefits of this role include:
Opportunity to lead regulatory intelligence initiatives in a global CRO environment.
Fully remote work with a supportive, flexible, and collaborative culture.
Exposure to cutting-edge AI and digital tools for regulatory strategy and intelligence.
Professional growth within a global organization of 100,000+ colleagues, emphasizing integrity, innovation, intensity, and involvement.
This role is ideal for professionals seeking to leverage regulatory expertise, shape strategic decisions, and influence global drug development programs.
Gujarat :
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Delhi | India | New Delhi | PAN-India |Assam :
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Rangpo |India :
Siliguri |Illinois :
Abbott Park | Bloomingdale | Champaign | Chicago | Deerfield | Glenview | Lake Forest | Lombard | Naperville | Norridge | Park RIdge | Round Lake |Maryland :
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Andover | Billerica | Boston | Cambridge | Devens | Lexington | Massachusetts | Medford and Somerville | Rockland |Wisconsin :
Appleton | Kenosha | Pleasant Prairie | Portage | Waukesha |United states :
Arizona | Buffalo Grove | Clayton | Downers Grove | fairmont | Georgia | Keene | Michigan | Mt. Pleasant | New Jersy | OH | Piedmont | Salisbury | United States | Whitesboro | Winston-Salem |Georgia :
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Duluth | Eden Prairie | Fridley | Hibbing | Maple Grove | Minneapolis and St. Paul, Minnesota. | Minnetonka | St.Paul |Kentucky :
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Arkansas | Remote Australia |New South Wales :
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Tallinn |Hà Nội :
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Tel Aviv | Yavne | Netanya | Kfar Saba | Be'Er Sheva |Remote :
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Kyiv |Lima Region :
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