Senior Start Up & Regulatory Specialist

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

📋 Description

• Ensure timely and high-quality site activation readiness within designated countries/sites while identifying and addressing potential risks.

• Manage submissions and site activation processes at the country level.

• Prepare Clinical Trial Application forms and submission packages for regulatory authorities, ethics committees, and relevant local entities.

• Engage with Competent Authorities and Ethics Committees, managing their responses effectively.

• Provide updates on submissions to Start Up/Regulatory Leads and Project Managers/Teams.

• Maintain project plans, trackers, and tools for regulatory intelligence.

• Assist with study-specific start-up plans, IMP release requirements, and criteria for essential document reviews.

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

• Prepare, review, and manage essential documents for site activation and IMP release.

• Tailor Patient Information Sheets and Informed Consent Forms to meet country/site-specific requirements.

• Coordinate the translation of documents needed for submissions.

• Liaise with Feasibility, Clinical Operations, Project Management, Regulatory, and Site Contracts teams regarding statuses and deliverables.

• Keep track of critical-path data at the site level concerning activation timelines, contracts, budgets, and necessary reviews.

• Provide support for study budget negotiations and the execution of investigator contracts when needed.

• Stay updated on local clinical trial laws and regulations, sharing knowledge internally.

• Ensure audit and inspection readiness and organize documents as per TMF or study-specific plans.

• Assist in Pre-Study Site Visits and feasibility site outreach as required.

• Contribute to country-specific start-up summaries, process flows, training sessions, and SME responses.

• Mentor team members on local regulations, submissions, procedures, guidance, and tools.

• Lead departmental process improvements and initiatives.

• Provide clients with updates on activation readiness and assist with proposals, presentations, and Kick-Off Meetings (KOMs).

• Serve as the Start Up Lead for smaller/single-country studies or as the regional Start Up Lead for larger global studies.

⛳️ Requirements

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

• Minimum of 5 years as a Regulatory or Start Up Specialist in a CRO or the pharmaceutical/biotech sector, or relevant experience demonstrating competencies.

• Strong communication and organizational skills.

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

• Fluency in both English and Turkish.

• Capability to prioritize tasks effectively to meet deadlines.

• Experience in driving cross-functional activities, along with coordination and oversight of teams.

• Relevant experience in regulatory and site start-up activities for Turkey, including feasibility assessments, contract negotiations, and CA/EC/IRB submissions.

• Familiarity with milestone tracking tools and systems.

• Solid understanding of Good Clinical Practice/ICH Guidelines and applicable regulatory requirements.

• Excellent skills in computer usage, communication, presentation, and interpersonal interactions.

• Willingness to undertake occasional travel as necessary.

🏝️ Benefits

• Employees are recognized for their contributions.

• Employees’ opinions and ideas are valued and promoted.

• Equal Opportunity Employer.

• Reasonable accommodations provided during the application process.