Senior Regulatory Intelligence Manager
Thermo Fisher Scientific
full-time
Posted on:
Location Type: Remote
Location: North Carolina • United States
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Job Level
About the role
- Monitor & Analyze: Track global regulatory changes, guidance documents, and policy trends across key markets (FDA, EMA, PMDA, etc.) or stakeholders (EU Commission, ICH, ISO, etc.).
- Impact Assessment: Liaise with relevant internal stakeholders and evaluate the implications of regulatory updates on the client's development programs and operational practices.
- Stakeholder Alignment: Interact with Regulatory Affairs, Clinical, Quality, Pharmacovigilance and Legal teams to ensure alignment and awareness with key areas of interest and hot topics.
- Communication: Contribute to the creation of and distribute internal newsletters, alerts, and briefing documents tailored to various audiences.
- Publish relevant selected content to internal Engage forum.
- Precedent Searches: Contribute to preparatory research and drafting of responses to precedent searches requests from various stakeholders.
- Knowledge Management: Maintain a centralized repository of regulatory intelligence resources and ensure accessibility across teams.
- External Engagement: Participate in industry forums, working groups, and regulatory intelligence networks to stay ahead of emerging trends.
Requirements
- Bachelor’s degree in life sciences or related field; advanced degree preferred.
- 10+ years of specialized experience in regulatory intelligence in US, EU and global (in the order of preference) within the biopharmaceutical industry.
- Strong understanding of global regulatory frameworks and drug development lifecycle.
- Excellent analytical, writing, and presentation skills.
- Perfect command of English.
- Proven ability to translate complex regulatory information into actionable insights.
- Strong project management and prioritization skills; ability to effectively manage multiple tasks and priorities.
- Experience with regulatory intelligence tools and databases (e.g., Clarivate, Citeline, etc.) as well as proficiency with generative AI concepts and use is a must.
- Available for approximately 20% travel.
- Business-level English proficiency required, additional languages beneficial.
Benefits
- Health and wellbeing support
- Flexible work arrangements
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
regulatory intelligenceglobal regulatory frameworksdrug development lifecycleanalytical skillswriting skillspresentation skillsproject managementprioritization skillsgenerative AI concepts
Soft Skills
communicationstakeholder alignmentability to translate complex informationinterpersonal skills