Global Regulatory CTA Co-ordinator (12m Contract - US Working Hours)

This a Full Remote job, the offer is available from: United States, Montenegro, Croatia, Serbia, Colorado (USA) For the past 20 years, ProPharma has improved the health and wellness of patients by providing advice and expertise that empowers biotech, med device, and pharmaceutical organizations of all sizes to confidently advance scientific breakthroughs and introduce new therapies. ProPharma partners with its clients through an advise-build-operate model across the complete product lifecycle. With deep domain expertise in regulatory sciences, clinical research solutions, quality & compliance, pharmacovigilance, medical information, and R&D technology, ProPharma offers an end-to-end suite of fully customizable consulting solutions that de-risk and accelerate our partners’ most high-profile drug and device programs. Full-time 12 Month contract role open for a Global Regulatory CTA Co-ordinator. Must be based in Croatia, Serbia, Montenegro or Bosnia, and able to work US hours (1-9 CET)

Key Responsibilities

• Collaborate closely with cross-functional teams and CRO partners to optimise and deliver the regulatory strategy for international trials
• Serve as the primary liaison with the CRO, providing expert oversight on CTA submissions, query resolution, and ongoing management
• Provide specialised regulatory guidance to the cross-functional team during preparation for CTA submissions
• Perform detailed review of comprehensive CTA packages (including Protocols, ICFs, IMPDs, and supporting documents) and issue the authoritative Regulatory greenlight for submission to Ministries of Health (MoH) and Ethics Committees (EC)
• Deliver clear, high-quality regulatory feedback on key documentation to strengthen submission readiness
• Facilitate proper archiving by supplying essential documents and regulatory correspondence to the internal Regulatory Operations team (no hands-on archival required)

Requirements

• Strong experience in regulatory affairs for clinical trials, with proven expertise in CTA / CTA-equivalent submissions in a global (ex-US) context
• In-depth knowledge of international regulatory requirements for clinical trial applications (MoH, EC/IRB interactions)
• Excellent collaboration and communication skills — experienced in liaising with CROs, internal cross-functional teams, and external stakeholders
• Strong analytical and review capabilities for complex submission packages (Protocols, ICFs, IMPDs, etc.)
• Demonstrated ability to provide clear regulatory greenlights and constructive feedback
• Meticulous attention to detail and a track record of supporting high-quality, timely regulatory submissions

We celebrate our differences and strive to create a workplace where each person can be their authentic self. We are committed to diversity, equity, and inclusion. Employees are encouraged to unleash their innovative, collaborative, and entrepreneurial spirits. With a holistic approach as an Equal Opportunity Employer, we provide a safe space where all employees feel empowered to succeed. All applications to roles at ProPharma are personally reviewed by a member of our recruitment team. We do not rely on AI screening tools to support our hiring process. You will always receive an outcome to your application so that you have an answer from us - whether you're successful or not. Whilst ProPharma supports remote working, we also recognise the value that comes from in person collaboration. As such, we encourage any new hires that are based within a reasonably short commute of one of our offices to work on a hybrid basis and spend some time working from that office location, as agreed with your manager. All applications will be treated on their own merit and candidates will not be at any advantage or disadvantage based on their proximity to an office.

• ProPharma Group does not accept unsolicited resumes from recruiters/third parties. Please, no phone calls or emails to anyone regarding this posting.*

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