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At Psi CRO Ag, we are seeking a highly skilled Regulatory Officer to join our team of experts in regulatory and ethics submissions of clinical studies.

Key Responsibilities
  • Prepare clinical trial submission dossiers for regulatory and ethics authorities, ensuring compliance with all relevant regulations and guidelines.
  • Communicate effectively with regulatory authorities, ethics committees, project teams, and vendors on regulatory-related matters, providing timely and accurate information.
  • Review translations of essential documents subject to clinical trial submission, ensuring accuracy and consistency.
  • Track the regulatory project documentation flow, ensuring all necessary documents are up-to-date and compliant.
  • Review documents to greenlight IP release to sites, ensuring all necessary approvals are in place.
  • Manage safety reporting to authorities, ensuring timely and accurate submissions.
  • Deliver regulatory training to project teams, providing education and support on regulatory requirements and best practices.
  • Assist with feasibility research and business development requests, providing regulatory expertise and guidance.
Requirements
  • College/University degree in a relevant field, such as life sciences, law, or a related field.
  • Minimum 1 year of prior industry experience in regulatory affairs or a related field.
  • Full working proficiency in English and Turkish, with excellent communication and writing skills.
  • Proficiency in MS Office applications, with experience in document management and tracking.
  • Ability to plan, multitask, and work in a dynamic team environment, with strong problem-solving and collaboration skills.