Regulatory Submissions Lead II

46 Premier Research Group SL; España; On-site; EUR 90,000 - 120,000; Full time

Job summary

Premier Research is seeking a Regulatory Submissions Lead II to join our Regulatory Submissions and Contracts team in Spain. You will lead regulatory strategy, submissions, and approvals across regions, coordinating multi-country CTAs and start-up activities for complex studies.

You will review key regulatory documents, manage risks, and mentor junior staff while collaborating with sponsors and project teams to ensure timely, compliant submissions throughout the study lifecycle.

Qualifications

• Experience leading Part I and Part II CTIS submissions.
• 8–10 years in regulatory submissions; at least 6 years in lead roles.
• Experience managing complex trials globally and across IP types.
• Strong knowledge of ICH/GCP, FDA/EU regulations, ISO14155.
• Ability to lead, mentor, and coordinate multi-disciplinary teams.

Responsibilities

• Lead and execute regulatory strategy, submissions, and approvals across countries throughout the study lifecycle.
• Coordinate and submit CTAs to regulatory bodies, import/export licenses, and other regulatory applications.
• Ensure timely submission of modifications and trial notifications for maintenance studies.
• Own submission documentation and regulatory content quality for core documents.
• Review clinical/regulatory documents for compliance and country-specific requirements.
• Drive start-up readiness and activation strategies in partnership with cross-functional teams.

Skills

Regulatory submissions

Project management

Cross-functional collaboration

Regulatory risk management

CTIS experience

Education

University degree in pharmacy, medicine or related natural sciences

Tools

CTIS system

Regulatory databases

Job description

Premier Research is looking for a Regulatory Submissions Lead II to join our Regulatory Submissions and Contracts team. You will help biotech, medtech, and specialty pharma companies transform life-changing ideas and breakthrough science into new medicines, devices, and diagnostics. What we do is profoundly connected to saving and improving lives, and we recognize our team members are the most valuable asset in delivering success. We are here to help you grow, to give you the skills and opportunities to excel at work with the flexibility and balance your life requires. Your ideas influence the way we work, and your voice matters here. As an essential part of our team, you help us deliver the medical innovation that patients are desperate for. Join us and build your future here.

What You'll Be Doing:

• Lead and execute regulatory strategy, submissions, and approvals across all participating countries throughout the study lifecycle by developing and managing regulatory and start-up project plans;
• coordinating and submitting Clinical Trial Applications (CTAs) to all applicable regulatory bodies (Ethics Committee, Institutional Review Boards, Competent Authorities (CA, CEC/CIRB, LEC/LIRB)), import/export licenses, and other regulatory applications for multi-region and complex studies in start-up.
• For maintenance studies, ensures timely submission of substantial and non-substantial modifications, and all required trial notifications, including first patient in, end of trial, temporary halts and early terminations until Clinical Study Reports.
• For EU interventional clinical studies, directly lead and execute activities within the Clinical Trial Information System (CTIS), owning the development of the overall regulatory submission strategy as well as the preparation and completion of the Part I.
• Act as the primary regulatory & submissions lead for sponsors and project teams, ensuring alignment on timelines, deliverables, submission strategies, document readiness, and regulatory requirements.
• Proactively identify, communicate, and manage risks, issues, and contingency plans; escalated critical concerns; provide recommendations for resolution; and lead regulatory and submission-related discussions during kick‑off meetings, and internal/external study calls.
• Own submission documentation and regulatory content quality by preparing, reviewing, and securing sponsor approval of core submission documents such as application forms, cover letters, Patient Information Sheets/Informed Consent Forms (PIF/ICF); import/export applications; and country-specific submission packages.
• Review essential clinical and regulatory documents including IMPDs, protocols, Investigator's Brochures, master/country informed consent forms, investigational product labels, and other regulatory materials to ensure compliance, completeness, quality, and country-specific acceptability requirements.
• Drive start‑up readiness by defining and agreeing Greenlight Package templates with sponsors, coordinating the completion of country and site greenlight packages with Study Start‑Up Associates (SSUAs), and supporting overall country and site activation strategies in partnership with other functional areas to ensure efficient progression from regulatory approval to site activation.
• Maintain operational excellence, compliance, and financial oversight by ensuring high-quality execution of all regulatory and start‑up activities, staying current with evolving regulations and guidance, supporting continuous process improvement initiatives, monitoring study start‑up budgets and contractual obligations and identifying out‑of‑scope activities related to their functional area.
• Provide leadership, expertise, and business support by serving as a subject matter expert in specialized areas and complex studies such as GMO, MedTech, or other regulatory domains; coaching, mentoring, supervising, and training junior staff; leading departmental improvement initiatives; and contributing to business development activities through client meetings, bid defenses, design presentations, and strategic regulatory input during proposal development.

What We Are Searching For:

• Education to university degree level (pharmacy, medicine or related natural sciences are a plus)
• 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 in managing submission of complex trials, different IP types and different phases, globally
• Experience in MD/IVDR and GMO is highly recommended
• Excellent knowledge of ICH/GCP regulations/country specific regulations as applicable.
• Excellent knowledge of FDA Guidance Documents/EU Regulations/ISO14155 regulations, drug / device development, and start‑up procedures.
• Excellent team player, collaborative and able to build an effective team.
• Ability to multitask and work effectively in a fast‑paced environment with changing priorities.
• Excellent organizational and time‑management skills, able prioritize work to meet deadlines.
• Accountable, dependable and strong commitment to quality.
• Customer service focused approach to work both internally and externally.
• Premier Research is more than a company – it's a community furthering research to improve the lives of patients in critical need.
• We are a diverse staff thinking creatively, challenging ideas, and solving complex problems.
• Our Values - We Aim High, We Work Together, We Stay Agile, We Get It Done, We Care - mirror the determination, flexibility and trust that our team embodies.
• As a Premier team member, you have the power to make an impact, regardless of job title and location.
• Our dedication to biotech and specialty pharma is unlike any other.
• We provide our staff with innovative technologies and continuous learning.
• We aim high - we will not stop until we reach our goals.
• And we care about each other, about our customer and partners, and, most importantly, about all the patients that we touch with our work.

Premier Research is a global clinical research, product development, and consulting company. We are dedicated to helping biotech, specialty pharma, and MedTech innovators transform life‑changing ideas and breakthrough science into new medical treatments. Our team is inspired by this common purpose. Premier is a place where you can change lives, and feel rewarded and celebrated. We aim high - we will not stop until we reach our goals. And we care about each other, about our customer and partners, and, most importantly, about all the patients that we touch with our work.