Principal Regulatory and Start Up Specialist

This is a fully remote position, open to applicants in Turkey.

📋 Description

• Accountable for ensuring timely and quality site activation readiness within designated countries/sites while identifying and mitigating potential risks.

• Tasked with facilitating country-level submissions and overseeing site activation processes by coordinating activities across multiple RSSs assigned within the country.

• Responsible for the preparation of Clinical Trial Application Forms and the creation of submission dossiers (initial submissions and amendments/notifications) for submission to CA, EC, and other relevant local authorities, adhering to local requirements and timelines to secure all necessary authorizations/approvals for conducting Clinical Trials in compliance with international and local/national regulations, company SOPs, and ICH-GCP principles.

• Engaging with CA/EC for study-related purposes and managing responses to these authorities.

• Providing consistent updates regarding CA and EC submissions to the Start-Up Lead and/or Regulatory Lead involved in the study, as well as to the Project Manager/Project Team as necessary.

• Maintaining project plans, trackers, and regulatory intelligence tools pertinent to assigned responsibilities, while keeping Regulatory Leadership informed.

• Assisting in the development of study-specific start-up plans, IMP release requirements, and essential document review criteria.

• Collaborating with the assigned site CRA to ensure effective communication and site cooperation.

• Preparing, reviewing, and managing the collection of essential documents necessary for site activation and IMP release.

• Customizing Patient Information Sheets and Informed Consent Forms specific to the country/site.

• Responsible for facilitating the translation and coordination of translations for submission-required documents.

• Maintaining communication with other key functions involved in country start-up, including Feasibility, Clinical Operations, Project Management, Regulatory, and Site Contracts management groups, regarding project-specific status and deliverables.

⛳️ Requirements

• A Bachelor’s degree in life sciences or a related field (preferably in a scientific or healthcare discipline), or a Registered Nurse (RN) qualification, or an equivalent combination of education, training, and experience.

• A minimum of 5 years of experience as a Regulatory or Start-Up specialist in a CRO or the pharmaceutical/biotech industry, or equivalent relevant experience and demonstrated competencies.

• Exceptional communication and organizational skills are a must.

• Proficiency in using computerized information systems, electronic spreadsheets, word processing, and email software is required.

• Fluency in English and Turkish is essential.

• Ability to prioritize tasks effectively to meet deadlines.

• Experience in leading cross-functional activities, coordinating, and overseeing a team is preferred.

🏝️ Benefits

• We are dedicated to ensuring that our employees feel valued for their contributions every day.

• You will have the opportunity to share your insights and have your ideas recognized and supported, driving positive change within the company.