Regulatory Submissions Lead II

🔥 0 minutes ago

🌐 Spain, Hungary, +3 more countries – Remote

🇪🇸 Spain – Remote 🇭🇺 Hungary – Remote 🇧🇬 Bulgaria – Remote 🇷🇴 Romania – Remote 🇵🇹 Portugal – Remote

⏰ Full Time

🟠 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 to applicable regulatory bodies, import/export licenses, and other regulatory applications • Submit substantial and non-substantial modifications and required trial notifications for maintenance studies • Lead and execute EU interventional clinical study activities in CTIS, including overall submission strategy and Part I preparation and completion • Act as primary regulatory and submissions lead for sponsors and project teams • Align timelines, deliverables, submission strategies, document readiness, and regulatory requirements • Identify, communicate, and manage risks, issues, and contingency plans; escalate critical concerns and recommend resolutions • Lead regulatory and submission discussions during kick-off meetings and internal/external study calls • Prepare, review, and secure sponsor approval of core submission documents and country-specific submission packages • Review clinical and regulatory documents for compliance, completeness, quality, and country-specific acceptability • Define Greenlight Package templates and coordinate country and site greenlight packages with Study Start-Up Associates • Support country and site activation strategies with other functional areas • Ensure high-quality, compliant regulatory and start-up execution • Monitor study start-up budgets and contractual obligations and identify out-of-scope activities • Serve as subject matter expert for specialized areas and complex studies, including GMO and MedTech • Coach, mentor, supervise, and train junior staff • Lead departmental improvement initiatives • Contribute to business development through client meetings, bid defenses, design presentations, and strategic regulatory input during proposal development

🎯 Requirements

• Education to university degree level • Hands-on experience with Part I and Part II submissions in CTIS • 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 in MD/IVDR and GMO highly recommended • 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 collaborate and build an effective team • Ability to multitask effectively in a fast-paced environment with changing priorities • Excellent organizational and time-management skills; ability to prioritize work and meet deadlines • Accountability, dependability, and strong commitment to quality • Customer-service-focused approach for internal and external work

🏖️ Benefits

• Flexibility and balance to support your life • Skills and opportunities for professional growth • Coaching, mentoring, supervision, and training opportunities • Participation in departmental improvement initiatives • Contribution to business development activities