Senior Regulatory and Start Up Specialist

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

📋 Description

• Accountable for ensuring timely and high-quality site activation readiness within the designated country/sites, while 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.

• Preparation of Clinical Trial Application Forms along with the submission dossier (initial 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 the Clinical Trial in accordance with 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, and to the Project Manager/Project Team as needed.

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

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

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

• Prepare, review, and manage the collection of essential documents necessary for site activation/IMP release.

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

• Oversee and facilitate the translation and coordination of translations for documents needed for submission.

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

• Serve as a Subject Matter Expert (SME) for collecting and maintaining site-level critical path data points related to Site Activation, which include Competent Authority, local IRB/Ethics Committee (EC) timelines, site contracts, budget negotiation requirements, and other necessary reviews to ensure timely site activation for the assigned sites within the country.

• When necessary, engage in the negotiation of study budgets and the execution of investigator contracts under the guidance of the Site Contract Management department or designee.

• Keep abreast of local clinical trial laws and regulations, and assist in disseminating this knowledge within PfM to ensure compliance with international and local/national regulations during the conduct of Clinical Trials.

• Ensure audit/inspection readiness at all times and organize documents according to the TMF plan and/or study-specific plans in the relevant TMF.

• May assist the clinical team with Pre-Study Site Visits.

• May support the feasibility group in site outreach to gauge potential interest from investigators for a prospective study.

• Will aid in the development of a country-specific Country Start-up summary and process flow that identifies timelines, risks, and success factors.

• Will contribute to the creation of training sessions to enhance Country Start-up knowledge and act as a Subject Matter Expert for inquiries.

• Will mentor staff on local country regulations, submissions, and internal procedures, as well as on PFM SSU-specific guidance and tools.

• Can take ownership of departmental process improvements/initiatives, including finalization, rollout, and periodic reviews.

• May collaborate with clients to provide updates on activation readiness status, request documents or document reviews, and participate in proposal activities, including slide development and client presentations as necessary.

⛳️ 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.

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

🏝️ Benefits

• Excellent communication and organizational skills are essential.

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

• Fluency in English and Turkish.

• Ability to prioritize workload effectively to meet deadlines.

• Experience in driving cross-functional activities, coordination, and oversight of a team.