Overview
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 Latvia.
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.
Responsibilities
• Prepare, review, and file initial clinical trial applications to regulatory authorities and Ethics committees in Latvia;
• 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 assess 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 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;
• Relevant working experience at a CRO, Pharmaceutical Company, or an investigative site;
• 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 Latvian and English; and
• Great attention to detail and excellent oral and written communication skills.
We kindly ask to submit applications in English.
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Apply Now