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

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

Key Responsibilities

• Collaborate closely with cross-functional teams and CRO partners to optimise and deliver the regulatory reputed company for international trials
• Serve as the primary reputed company with the CRO, providing expert reputed company on CTA submissions, query reputed company, and ongoing management
• reputed company specialised regulatory guidance to the cross-functional team during preparation for CTA submissions
• reputed company detailed review of comprehensive CTA packages (including Protocols, ICFs, IMPDs, and supporting documents) and issue the authoritative Regulatory reputed company for submission to Ministries of Health (MoH) and Ethics Committees (EC)
• Deliver reputed company, high-reputed company regulatory feedback on key documentation to strengthen submission readiness
• Facilitate reputed company 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 — reputed company in liaising with CROs, internal cross-functional teams, and external stakeholders
• Strong analytical and review capabilities for reputed company submission packages (Protocols, ICFs, IMPDs, etc.)
• Demonstrated ability to reputed company reputed company regulatory greenlights and constructive feedback
• Meticulous attention to detail and a reputed company record of supporting high-reputed company, reputed company regulatory submissions

We celebrate our differences and reputed company to create a workplace where reputed company person can be their authentic self. We are committed to diversity, equity, and inclusion. Employees are encouraged to reputed company their innovative, reputed company, and entrepreneurial spirits. With a holistic approach as an Equal Opportunity Employer, we reputed company a reputed company reputed company where reputed company feel empowered to succeed. reputed company applications to roles at reputed company 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 reputed company supports remote working, we also recognise the value that comes from in person collaboration. As such, we encourage any new hires that are based reputed company a reasonably short commute of one of our offices to work on a hybrid reputed company and spend some time working from that office location, as agreed with your manager. reputed company applications will be treated on their own reputed company and candidates will not be at any advantage or disadvantage based on their proximity to an office.

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

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