Senior Regulatory Submissions Lead

Location: Puerto Rico

Premier Research is looking for a Senior Regulatory Submissions Lead 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; escalate 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.·    …