Senior Regulatory Affairs Specialist – Trial Transparency Liaison

🔥 0 minutes ago

🌐 United Kingdom, Belgium, +4 more countries – Remote

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

⏰ Full Time

🟠 Senior

🚔 Compliance

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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 strategic regulatory intelligence and guidance supporting product development from preclinical stages through registration and product optimization • Prepare client deliverables meeting current local, regional, and ICH regulatory and technical requirements • Act as a liaison with internal and external clients in providing and marketing regulatory services • Lead and oversee transparency activities at the CTT level, including protocol registration, result posting, and redaction of CTIS documents • Support IDT-level transparency activities, including anonymization and/or redaction of post-marketing approval documents • Manage and coordinate global disclosure and transparency deliverables in accordance with company transparency policy • Initiate and maintain clinical trial registration in global trial registries, including ClinicalTrials.gov and CTIS • Lead and coordinate result posting in global trial registries • Manage and coordinate CTIS document redactions, including identification of commercially confidential information • Maintain knowledge of evolving global transparency and disclosure regulations • Provide or lead transparency activities as directed • Prepare and review regulatory submissions • Provide regulatory strategy and technical advice to internal and external clients • Lead development and implementation of project-specific sponsor processes • Collaborate with departments, regulatory consultants, and regulatory authorities • Identify out-of-scope contract activities and coordinate contract modifications • Provide training and guidance to junior team members • Participate in project launch, review, and project team meetings • Support business development, including project budgeting and forecasting

🎯 Requirements

• Bachelor's degree or equivalent and relevant formal academic / vocational qualification • Previous experience comparable to 5+ years • 3+ years of experience in clinical trials • Experience in a transparency position (protocol registration, CTIS redaction, clinicaltrials.gov) is a plus • Experience in and understanding of global clinical trial transparency regulations • Familiarity with clinical trial documents and clinical study and clinical development design • Strong English language written and oral communication skills, as well as local language where applicable • Strong editorial/proofreading skills and attention to detail and quality • Strong interpersonal, organizational, time management, planning, negotiation, analytical, investigative, and problem-solving skills • Microsoft Word, Excel, PowerPoint, and Adobe Acrobat Pro proficiency • Ability to learn new technologies • Ability to work independently and exercise independent judgment • Understanding of global/regional/national clinical trial authorization, licensing, lifecycle management, ICH, and other global regulatory guidelines • Understanding of medical terminology, statistical concepts, and guidelines • Working knowledge of budgeting and forecasting • Ability to multitask and prioritize effectively in a fast-paced environment • Ability to oversee CTT transparency activities • High adaptability and self-motivation • Occasional travel, including domestic and international travel • In some cases, an equivalency consisting of appropriate education, training, and/or directly related experience may be considered sufficient

🏖️ Benefits

• Fully remote work arrangement • Full-time employment

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