Thermo Fisher Scientific
The World Leader In Serving Science
Senior Regulatory Intelligence Manager
Location
North Carolina
Posted
46 days ago
Salary
Not specified
Seniority
Senior
Bachelor Degree10 yrs expEnglish
Job Description
• 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.
Job 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
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