Regulatory Intelligence Manager – FSP

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November 16

🌲 North Carolina – Remote

Although this job is listed in North Carolina, this company may be open to hiring remote in other states.

🔔 Pennsylvania – Remote

Although this job is listed in Pennsylvania, this company may be open to hiring remote in other states.

⏰ Full Time

🟡 Mid-level

🟠 Senior

🚔 Compliance

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Thermo Fisher Scientific

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Biotechnology • Pharmaceuticals • Science

Thermo Fisher Scientific is the world leader in serving science, with annual revenue of more than $40 billion. Their mission is to enable customers to make the world healthier, cleaner, and safer by supporting life sciences research, solving complex analytical challenges, increasing laboratory productivity, and improving patient health through diagnostics and the development of life-changing therapies. With a global team, they offer innovative technologies and pharmaceutical services through brands such as Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services, Patheon, and PPD.

10,000+ employees

Founded 1956

🧬 Biotechnology

💊 Pharmaceuticals

🔬 Science

📋 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. • 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. • 5+ years of specialized experience in regulatory intelligence 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.

🏖️ Benefits

• Reasonable accommodation for individuals with disabilities