Regulatory and Start Up Specialist

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About This Role

Precision for Medicine operates as a global clinical research organization that integrates novel trial designs, operational and medical experts, and advanced biomarker and data analytics solutions. The company specializes in rare diseases and oncology, alongside other therapeutic areas. To support ongoing expansion, the organization seeks a Regulatory and Start Up Specialist based in the UK to join its growing team. This full-time remote role focuses on delivering timely and high-quality…

Job Description

Responsibilities

• Manage the timely and high-quality delivery of site activation readiness for assigned sites while identifying and mitigating risks
• Prepare clinical trial application forms and submission dossiers for initial applications, amendments, and notifications to competent authorities and ethics committees
• Interact with competent authorities and ethics committees for study purposes and handle responses
• Provide regular updates regarding submissions to the start-up lead, regulatory lead, project manager, and project team
• Maintain project plans, trackers, and regulatory intelligence tools
• Support the development of study-specific start-up plans, IMP release requirements, and essential document review criteria
• Partner with assigned site clinical research associates to ensure aligned communication and secure site activation
• Review and manage the collection of essential documents needed for site activation and IMP release
• Customize country and site-specific patient information sheets and informed consent forms
• Facilitate document translations and coordinate translation processes
• Collaborate with feasibility, clinical operations, project management, regulatory, and site contracts management groups
• Act as a subject matter expert for collecting and maintaining site-level critical path data points to site activation
• Negotiate study budgets and execute investigator contracts under the direction of the site contract management department
• Support the feasibility group in site outreach to assess investigator interest
• Distribute knowledge of local clinical trial laws and regulations internally
• Maintain audit and inspection readiness and file documents according to trial master file plans
• Support the clinical team in performing pre-study site visits when required

Requirements

• At least 2 years of relevant experience
• Previous experience working as a regulatory and start-up specialist or site contracts specialist in a CRO, pharmaceutical industry, or biotech industry
• Strong communication and organizational skills
• Proficiency in computerized information systems, electronic spreadsheets, word processing, and electronic mail
• Fluency in English
• Legal authorization to work in the country of employment without employer sponsorship

Qualifications

• Bachelor degree in life sciences, a scientific or healthcare discipline, or related field
• Registered Nurse certification or equivalent combination of education, training, and experience
• Pharmacy qualification or work experience as a pharmacist
• Previous experience with regulatory and site start-up including feasibility, contract negotiations, and submissions
• Experience in site contract and budget negotiation
• Experience using milestone tracking tools and systems
• Ability to prioritize workload to meet deadlines
• Advanced degree in medical or life sciences such as an MD, PhD, or PharmD
• RAC certification
• Masters degree in Regulatory Science

Core Skills

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