ProPharma

Global Regulatory CTA Coordinator – 12m Contract

ProPharma

contract

Posted on:

Location Type: Hybrid

Location: Croatia

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About the role

  • 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
Benefits
  • 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.
Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills & Tools
regulatory affairsCTA submissionsclinical trialsregulatory guidancesubmission packages reviewregulatory feedbackregulatory greenlightinternational regulatory requirementsprotocolsICFs
Soft Skills
collaborationcommunicationanalytical skillsattention to detailstakeholder managementquery resolutionoversightconstructive feedbackmeticulousnesssubmission readiness