Principal Regulatory and Start Up Specialist

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

📋 Description

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

• Responsible for managing country-level submissions and site activation processes by coordinating activities among multiple RSSs assigned within the country.

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

• Engage with CA/EC for study-related purposes and manage responses to the CA/EC.

• Provide regular updates on CA and EC submissions to the Start-Up Lead and/or Regulatory Lead assigned to the study, as well as to the Project Manager/Project Team as needed.

• Maintain project plans, project trackers, and regulatory intelligence tools related to assigned responsibilities, ensuring Regulatory Leadership is kept informed.

⛳️ Requirements

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

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

• Familiarity with Good Clinical Practice/ICH Guidelines and other applicable regulatory requirements.

• Must exhibit strong computer skills.

🏝️ Benefits

• Outstanding communication and organizational skills are crucial.

• Proficient in using computerized information systems, electronic spreadsheets, word processing, and electronic mail.

• Fluency in both English and Turkish.

• Capability to prioritize workload effectively to meet deadlines.

• Experience in facilitating cross-functional activities, coordinating, and overseeing a team.