Regulatory Operations Specialist II

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.