Senior Regulatory Submissions Lead

🔥 0 minutes ago

🌐 Spain, Italy, +4 more countries – Remote

🇪🇸 Spain – Remote 🇮🇹 Italy – Remote 🇭🇺 Hungary – Remote 🇩🇪 Germany – Remote 🇫🇮 Finland – Remote 🇺🇸 United States – Remote

⏳ Contract/Temporary

🟠 Senior

🚔 Compliance

👻 Ghost score 10%

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Premier Research

WebsiteLinkedInAll Job Openings

1001 - 5000 employees

🏥 Healthcare

💼 Consulting

🧬 Biotechnology

💰 Venture Round on 2016-10

Healthcare • Consulting • Biotechnology

Premier Research is a company dedicated to helping biotech companies transform groundbreaking scientific ideas into life-changing medical treatments. They specialize in clinical research and development, product development and regulatory consulting, and offer expertise in areas such as oncology, hematology, rare diseases, cell and gene therapy, and pediatrics, among others. Premier Research is committed to boosting clinical development strategies and guiding innovations from molecule to market. They provide a range of services that support biotech firms in navigating the complex path to medical approval, with a focus on rare diseases and innovative therapies.

📋 Description

• Lead and execute regulatory strategy, submissions, and approvals across participating countries throughout the study lifecycle • Develop and manage regulatory and start-up project plans • Coordinate and submit Clinical Trial Applications, import/export licenses, and other regulatory applications for multi-region and complex studies • Submit substantial and non-substantial modifications and required trial notifications through Clinical Study Reports • Lead and execute EU interventional clinical study activities in CTIS, including overall regulatory submission strategy and Part I preparation and completion • Serve as the primary regulatory and submissions lead for sponsors and project teams • Align timelines, deliverables, submission strategies, document readiness, and regulatory requirements • Identify and manage risks, issues, and contingency plans; escalate concerns and recommend resolutions • Lead regulatory and submission discussions in kick-off meetings and internal/external study calls • Prepare, review, and secure sponsor approval of core submission documents and country-specific packages • Review IMPDs, protocols, Investigator's Brochures, informed consent forms, investigational product labels, and other regulatory materials • Define Greenlight Package templates and coordinate country/site packages with Study Start-Up Associates • Support country and site activation strategies with other functional areas • Ensure operational excellence, compliance, quality execution, and financial oversight • Monitor start-up budgets and contractual obligations and identify out-of-scope activities • Serve as a subject matter expert in GMO, MedTech, and other regulatory domains • Coach, mentor, supervise, and train junior staff • Lead departmental improvement initiatives and contribute to business development through client meetings, bid defenses, design presentations, and proposal development

🎯 Requirements

• Education to university degree level (pharmacy, medicine or related natural sciences are a plus) • 8–10 years' experience, including at least 6 years' experience as Regulatory Submissions Lead, Start-Up Lead, Submissions Manager, or equivalent • Experience managing submissions for complex trials, different IP types, and different phases globally • Experience managing the CTIS system • Excellent knowledge of ICH/GCP regulations and applicable country-specific regulations • Excellent knowledge of FDA Guidance Documents, EU Regulations, ISO 14155 regulations, drug/device development, and start-up procedures • Ability to work accurately and interpret relevant directives and guidelines • Ability to fulfill objectives and complete projects within agreed budgets and timelines • Ability to multitask and work effectively in a fast-paced environment with changing priorities • Excellent organizational and time-management skills, with ability to prioritize work to meet deadlines • Accountable, dependable, and strongly committed to quality • Customer-service-focused approach to internal and external work • Available at short notice and set up to work as a freelancer/contractor

🏖️ Benefits

• Flexibility and balance to accommodate life requirements • Freelance / contract opportunity offered as a full FTE for up to 6 months • Opportunities for professional growth, skills development, and career advancement