Senior Start Up & Regulatory Specialist

🔥 0 minutes ago

🇹🇷 Turkey – Remote

⏰ Full Time

🟠 Senior

🚔 Compliance

👻 Ghost score 10%

What it means: how likely this posting is sitting open without active hiring.How to read it: 60% or higher means we think this is a ghost. Lower scores are less of a worry.How we score it: age, reposts, open roles vs team size, how fast jobs close, and whether pay is listed.Fine print: an estimate from public data, not a judgment of the company. Real jobs can score high, so treat it as a hint, not a fact.

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Precision For Medicine

WebsiteLinkedInAll Job Openings

1001 - 5000 employees

🏥 Healthcare

💼 Consulting

📦 Logistics

💰 $75M Private Equity Round on 2015-12

Healthcare • Consulting • Logistics

Precision For Medicine is a leading organization that specializes in supporting the development and commercialization of innovative therapies, particularly in oncology, rare diseases, and autoimmune conditions. With a comprehensive range of services including clinical trial management, lab services, and biospecimen collection, they integrate advanced biomarker capabilities and manufacturing solutions to streamline the complex clinical development processes. Their mission is to accelerate research and bring life-changing medical solutions to patients by overcoming traditional inefficiencies typically found in the pharmaceutical development landscape.

📋 Description

• Deliver timely and high-quality site activation readiness within assigned country/sites and foresee and mitigate risks • Drive country-level submissions and site activation processes by coordinating activities among multiple Regulatory and Start-Up Specialists • Prepare Clinical Trial Application forms and submission dossiers for competent authorities, ethics committees, and other local bodies • Interact with competent authorities and ethics committees and handle responses • Provide submission updates to Start Up and Regulatory Leads, Project Managers, and project teams • Maintain project plans, trackers, and regulatory intelligence tools • Prepare or support study-specific start-up plans, IMP release requirements, and essential document review criteria • Partner with assigned site CRAs to align communication and secure site collaboration • Prepare, review, and manage essential documents for site activation and IMP release • Customize country/site-specific Patient Information Sheets and Informed Consent Forms • Coordinate document translations required for submissions • Communicate with Feasibility, Clinical Operations, Project Management, Regulatory, and Site Contracts teams about project status and deliverables • Act as subject matter expert for site-level critical-path activation data, timelines, contracts, budget negotiations, and required reviews • Support study-budget negotiations and investigator-contract execution when required • Maintain knowledge of local clinical-trial laws and regulations and distribute this knowledge within Precision for Medicine • Maintain audit and inspection readiness and file documents according to TMF or study-specific plans • Support Pre-Study Site Visits and feasibility site outreach when required • Support country-specific start-up summaries, process flows, training sessions, and subject-matter-expert query resolution • Mentor staff on local regulations, submissions, internal procedures, and start-up guidance/tools • Own departmental process improvements and initiatives • Provide clients with activation-readiness updates, request or review documents, and support proposal activities and client presentations • Act as Start Up Lead for smaller or single-country studies or regional Start Up Lead on larger global studies • Participate in client kick-off meetings, including slide development and presentations

🎯 Requirements

• Bachelor’s degree in life sciences or related field, or Registered Nurse (RN), or equivalent combination of education, training, and experience • 5 years or more as a Regulatory or Start Up specialist in a CRO or pharmaceutical/biotech industry, or equivalent relevant experience and/or demonstrated competencies • Excellent communication and organizational skills • Experience using computerized information systems, electronic spreadsheets, word processing, and electronic mail • Fluency in English and Turkish • Ability to prioritize workload to meet deadlines • Experience driving cross-functional activities, coordination, and oversight of a team • Relevant regulatory and site start-up experience for Turkey, including feasibility, contract negotiations, and CA/EC/IRB submissions • Experience using milestone tracking tools/systems • Knowledge of Good Clinical Practice/ICH Guidelines and applicable regulatory requirements • Excellent computer skills • Ability to work independently in a fast-paced environment • Occasional travel may be required

🏖️ Benefits

• Employees feel appreciated for their contributions • Employee input and ideas valued and nurtured • Opportunity to impact positive change for the company • Occasional travel may be required