Our European activities are growing rapidly, and we are currently seeking a full-time, home-based Regulatory Submissions Coordinator & Contract Specialist (Dual role) to join our Clinical Operations team, in the country of Georgia. This is a new, permanent, entity for us and so our recruitment processes may be extended and some benefits may be confirmed but not yet in place depending on candidates preferred start date.

As a Regulatory Submissions Coordinator & Contract Specialist (Dual role) you will have the opportunity to work within Regulatory Submissions and contract negotiations, supporting our many projects. You will be a productive member of the team and will be mentored and supported as you develop your skills. Working directly with Regulatory Submissions Coordinators and Contract Specialists, you will gain valuable hands-on experience to enable you to develop a career in clinical research.

Please note that this role is not US based and you must be located in the country of Georgia to be considered.

Responsibilities

• Prepare, review, and file initial clinical trial applications to regulatory authorities and Ethics committees in Georgia;
• Prepare and submit responses to queries and amendments to clinical trial applications;
• Ensure submissions comply with applicable regulations and guidance documents;
• Advise team members on changing regulations and compliance requirements;
• Maintain the Clinical Trial Management System and ensure timely filing of documents;
• Collection of essential documents and preparation essential documents packages for drug release.
• Drafting, reviewing, negotiating, and finalizing agreements, termination letters or other legal documents required for a clinical study;
• Identify and assesses legal, financial, and operational risks and escalate to appropriate Contract Lead or Contract Manager;
• Provide recommendations and alternative resolutions throughout negotiations using established escalation channels;
• Coordinate with internal functional departments to ensure various site startup activities are aligned with contractual process and mutually agreed up timelines.

Qualifications

• A minimum of a Bachelor's degree is required (preferably in a Life Sciences field or Law);
• Experience preparing, reviewing, and submitting regulatory documentation to Ethics Committees and Regulatory Agencies; including formulating responses to queries;
• No previous industry experience mandatory for junior position level;
• Relevant working experience at a CRO, Pharmaceutical Company, or an investigative site for senior level;
• Knowledge of local regulatory guidelines and legislation;
• Excellent organizational and prioritization skills;
• Use to work independently with a proactive approach;
• Knowledge of Microsoft Office;
• Fluency in Georgian and English; and
• Great attention to detail and excellent oral and written communication skills.

We kindly ask to submit applications in English. Interested Candidates please click on the button "Send CV"