Iliyana Buteva

Responsibilies:
• Management of activities associated with obtaining initial, amendment and other central authority approvals and performing the relevant submission under CTR

Leading the activities connected with the EU CTR Process of submission on a study level (Part I) and Country level (Part II) for all of the participating countries

Coordinating the team , performing Meetings with presentations for the whole process of submissions, RFI responses, communication with the core team , taking decisions and providing support to go through the process smoothly.

Maintaining systems where all the submissions should be handled.
• Management of study level submissions associated with ensuring Investigational Product (IP) and any other clinical trial supplies can be imported and where applicable, exported

• Ensuring that IP labels are in adherence to country requirements and submitted where applicable
• Management of the study level Informed Consent and any other documentation given to patients i.e. diaries, questionnaires through to submission and approval by country level RA and Central IEC as appropriate
• Tracking and reporting of central submission/approval progress in all the respective systems
• Expert knowledge of current ICH and local Regulatory Agency and/or Ethics Committee regulations as they relate to pharmaceutical, biological, biosimilar, and medical device product development.

Review and negotiate Investigator contracts and budgets. Use sponsor approved fall-back language and budget parameters appropriatelyResponsible for the independent preparation, review and approval of country related submission packages in accordance with ICH, GCP and all applicable regulations, laws and other guidelines and ethical standards – within specific timelines and quality standards; responsible for independent preparation, review and approval of site level critical documents for Investigational Product (IP) release in accordance with regulatory / sponsor requirements – within specific timelines and quality standards; work with sites to finalize Site Specific Informed Consent Forms in accordance with ICON, site and sponsor specifications. Accountable for the collation and verification of the submission documentation in assigned countries; accountable for the dispatch and tracking of submissions to CA, ECs and other bodies as appropriate in assigned countries. . Maintain communication with Investigative sites, Sponsors and internal personnel regarding status of contract and contract-related documents

Responsible for the independent preparation, review and approval of country related submission packages in accordance with ICH, GCP and all applicable regulations, laws and other guidelines and ethical standards – within specific timelines and quality standards; responsible for independent preparation, review and approval of site level critical documents for Investigational Product (IP) release in accordance with regulatory / sponsor requirements – within specific timelines and quality standards; work with sites to finalize Site Specific Informed Consent Forms in accordance with ICON, site and sponsor specifications. Accountable for the collation and verification of the submission documentation in assigned countries; accountable for the dispatch and tracking of submissions to CA, ECs and other bodies as appropriate in assigned countries. Review and negotiate Investigator contracts and budgets. Use sponsor approved fall-back language and budget parameters appropriately. Maintain communication with Investigative sites, Sponsors and internal personnel regarding status of contract and contract-related documents

Preparation, distribution and tracking of ethics and regulatory submissions according to applicable regulations, SOPs and work instructions. Distribute completed documents to sites and internal project team members. Assist project team members in the identification of study sites. Review and negotiate site regulatory documents and contracts with sites and sponsors for agreement on wording and budgets. Work with Clinical Operations, Project Management and Site Identification on SSU project specific status and deliverables. Work with regulatory team members or sponsor to secure authorization of regulatory documents. Maintain and manage SSU data tracking entries in database. Review for completeness and accuracy