Regulatory Affairs Manager – Regulatory Intelligence

🔥 7 minutes ago

🌐 United Kingdom, Belgium, +3 more countries – Remote

🇬🇧 United Kingdom – Remote 🇧🇪 Belgium – Remote 🇫🇷 France – Remote 🇮🇹 Italy – Remote 🇳🇱 Netherlands – Remote

⏰ Full Time

🟠 Senior

🔴 Lead

🚔 Compliance

👻 Ghost score 10%

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Thermo Fisher Scientific

WebsiteLinkedInAll Job Openings

10,000+ employees

Founded 1956

🏥 Healthcare

📦 Logistics

🏭 Manufacturing

Healthcare • Logistics • Manufacturing

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.

📋 Description

• Provide technical and project leadership over one or more regions • Provide regulatory affairs expertise, client interface, strategic regulatory intelligence, and guidance from preclinical development through registration and product optimization • Prepare client deliverables meeting local, regional, and ICH regulatory and technical requirements • Act as liaison with internal and external clients in the provision and marketing of regulatory services • Monitor global regulatory changes, guidance documents, and policy trends across key markets and stakeholders • Assess regulatory impacts on client development programmes and operational practices • Translate regulatory findings into actionable insights and recommendations • Align with Regulatory Affairs, Clinical, Quality, Pharmacovigilance, and Legal teams • Create and distribute client newsletters, alerts, briefing documents, and selected Engage forum content • Conduct targeted regulatory precedent searches and synthesize findings • Maintain a centralized regulatory intelligence repository • Participate in industry forums, working groups, and regulatory intelligence networks • Review and advise on regional regulatory submissions • Provide regulatory strategy advice and technical expertise to internal and external clients • Ensure quality performance for key and managed projects • Manage project budgeting and forecasting • Identify out-of-scope contract activities and coordinate contract modifications • Collaborate with business development on pricing, presentations, proposals, and budgets • Provide matrix/project leadership, training, and guidance to junior team members • Ensure compliance with organizational and regulatory SOPs and WPDs • Participate in launch, review, and project team meetings

🎯 Requirements

• Bachelor's degree or equivalent and relevant formal academic / vocational qualification • 9+ years of previous experience providing the knowledge, skills, and abilities to perform the job • 5+ years of specialized experience in regulatory intelligence within the biopharmaceutical industry • Experience in CMC or a closely related function • Excellent English language written and oral communication skills, as well as local language where applicable • Strong understanding of global regulatory frameworks and the drug development lifecycle • Excellent analytical, writing, and presentation skills • Strong project management and prioritization skills • Experience with regulatory intelligence tools and databases, such as Clarivate and Citeline • Proficiency with generative AI concepts and use • Experience with agentic AI tools and workflows is highly desirable • Excellent attention to detail, quality, editorial, and proofreading skills • Exceptional interpersonal skills • Advanced Microsoft Word, Excel, and PowerPoint skills • Strong organizational, time management, and planning skills • Excellent negotiation skills • Ability to work independently and exercise independent judgment • Excellent understanding of global, regional, and national regulatory affairs procedures for clinical trial authorization, licensing, and lifecycle management • Expert knowledge of ICH and other global regulatory guidelines • Advanced understanding of regulatory specialty areas such as preclinical, clinical, CMC, or publishing • Superb understanding of medical terminology, statistical concepts, and guidelines • Excellent analytical, investigative, and problem-solving skills • Excellent understanding of budgeting and forecasting

🏖️ Benefits

• Fully remote work arrangement • Standard Monday–Friday work schedule

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