Regulatory Submissions Lead II

Premier Research Group; Argentina; On-site; ARS 138,487,000 - 230,812,000; Full time

Job summary

Premier Research Group seeks a Regulatory Submissions Lead II to join our Regulatory Submissions and Contracts team. You will help biotech, medtech, and specialty pharma clients transform ideas into medicines, devices, and diagnostics, driving regulatory success across regions.

You will lead regulatory strategy, coordinate CTAs, ensure compliance with ICH/GCP and country-specific requirements, and support start-up readiness while mentoring junior staff and collaborating with sponsors to achieve

Qualifications

• University degree in pharmacy, medicine or related natural sciences is preferred.
• Hands-on experience with EU CTIS Part I submissions and US IRB oversight.
• Experience in Argentine submission processes is required.
• 8-10 years of regulatory submissions experience, including at least 6 years in lead roles.
• Knowledge of ICH/GCP regulations and FDA/EU regulatory guidance.

Responsibilities

• Lead and execute regulatory strategy, submissions, and approvals across all participating countries.
• Act as primary regulatory & submissions lead for sponsors and project teams.
• Own submission documentation and regulatory content quality.
• Drive start-up readiness and country/site activation strategies.
• Maintain compliance, process improvement, and budget oversight.
• Mentor and develop junior staff and contribute to business development.

Skills

Regulatory submissions

Project management

Cross-country coordination

Education

University degree in pharmacy/medicine or related natural sciences

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; escalation 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 EU CTIS Part I submissions, US IRB oversight, and expertise in Argentine submission processes are a must.
• 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.