POSITION TITLE: Regulatory Operations Specialist II
DEPARTMENT: Ora Europe
LOCATION: UK or Europe
Ora Values the Daily Practice of...
Prioritizing Kindness * Operational Excellence * Cultivating Joy * Scientific Rigor
The Role:
The Regulatory Operations Specialist is responsible for assisting the Regulatory submissions team in QC, coordination of document preparation, management, and submissions within (and around) Europe. This is a team and individual contributor role, reporting to the Manager of Regulatory. This position will work collaboratively with regulatory, country CRA and project team. This position requires a strong technical background, a high degree of enthusiasm, enjoyment of working in a fast-paced environment, being self-motivated, and being able to use critical reasoning to solve problems and make decisions.
What You’ll Do:
Under the supervision of the European Regulatory Manager:
- Performs the role of a Regulatory Lead for studies within the European region during study start-up until study close out
- Oversees and performs quality control checks on clinical and regulatory documents, including Patient Information Sheet (PIS)/Informed Consent Form (ICF)
- Responsible for and contributes to preparation and submission of documents to regulatory authorities and ethics committees, primarily within the Clinical Trial Information System (CTIS)
- Performs quality control checks on study documents that are received from the sponsor and/or prepared by country CRAs to ensure all submission documents meet Ora’s submission standards
- Oversees, coordinates and contributes to development of country adapted study documents and ensuring documents are sponsor approved prior to finalization
- Contributes to the review and revision of standard operating procedures (SOPs), templates, and forms
- Performs data entry for tracking of regulatory submission activities
- Updates tracking logs, databases, and ensure filing of country adapted and sponsor approved study documents are filed in collaborative workspace
- Prepares the clinical trial application within CTIS for Part I with supervision; in compliance with forecasted timelines
- Escalates potential issues identified to impact forecasted timelines quickly
- May be required to provide regulatory support in other regions
- Keep up to date with current regulations, guidelines and changes in the industry
- Collaboration with Global Regulatory team and wider stakeholders
- Responsibilities may differ slightly from the above based on specific needs of the business.
- Clear and sustained demonstration of the Ora Clinical’s Values of prioritizing kindness, operational excellence, cultivating joy and scientific rigor.