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 across designated countries/sites while identifying and mitigating potential risks.

• Lead country-specific submissions and site activation procedures by coordinating efforts among various Regulatory and Start-Up Specialists.

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

• Engage with competent authorities and ethics committees, managing their responses effectively.

• Provide updates on submissions to Start Up and Regulatory Leads, Project Managers, and project teams.

• Maintain project plans, trackers, and regulatory intelligence resources.

• Develop or assist in creating study-specific start-up plans, IMP release requirements, and criteria for essential document reviews.

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

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

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

• Coordinate necessary document translations for submissions.

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

• Serve as a subject matter expert on site-level critical-path activation data, timelines, contracts, budget negotiations, and required reviews.

• Assist in study-budget negotiations and investigator-contract execution as needed.

• Stay updated on local clinical trial laws and regulations, disseminating this knowledge within Precision for Medicine.

• Ensure audit and inspection readiness, filing documents in accordance with TMF or study-specific plans.

• Support Pre-Study Site Visits and feasibility outreach when necessary.

• Contribute to country-specific start-up summaries, process flows, training sessions, and resolution of subject-matter-expert queries.

• Mentor staff on local regulations, submission processes, internal procedures, and start-up guidance/tools.

• Lead departmental process enhancements and initiatives.

• Update clients on activation-readiness, request or review documents, and assist with proposal activities and client presentations.

• Assume the role of Start Up Lead for smaller or single-country studies or act as the regional Start Up Lead for larger global studies.

• Participate in client kick-off meetings, including developing slides and delivering presentations.

⛳️ Requirements

• Bachelor's degree in life sciences or a related field, or Registered Nurse (RN), or a comparable combination of education, training, and experience.

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

• Strong communication and organizational skills.

• Proficient 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, coordinating, and overseeing a team.

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

• Familiarity with milestone tracking tools/systems.

• Knowledge of Good Clinical Practice/ICH Guidelines and applicable regulatory standards.

• Excellent computer proficiency.

• Ability to work independently in a high-paced environment.

• Occasional travel may be necessary.

🏝️ Benefits

• Employees are recognized for their contributions.

• Employee insights and ideas are valued and encouraged.

• Opportunity to foster positive change within the company.

• Occasional travel may be necessary.