Job Title: Country Approval SpecialistLocation: Remote (UK Based)Contract: 6 MonthsOverview:The Country Approval Specialist manages the preparation, review and coordination of Country Submissions in line with global submission.Responsibilities:Prepare, review, and coordinate local regulatory submissions (e.g., MoH, EC, gene therapy approvals, viral safety dossiers, import license) in alignment with the global submission strategy under guidance.Provide local regulatory strategy advice (MoH and/or EC) under guidance.Provide project-specific local Site Initiation Activities (SIA) services and coordinate these projects.Serve as a key contact at the country level for Ethical or Regulatory submission-related activities.Maintain contact with investigators for submission-related activities, as applicable.Coordinate with internal functional departments to align site start-up activities with submission activities and mutually agreed timelines.Ensure submission processes for sites and studies align with the critical path for site activation.Achieve target cycle times for site start-up activities.Collaborate with start-up CRA(s) to prepare regulatory compliance review packages, as applicable.Develop country-specific Patient Information Sheet/Informed Consent Form documents, as required.Assist with grant budgets and payment schedule negotiations with sites.Support coordination of feasibility activities according to agreed timelines.Enter and maintain trial status information related to SIA activities accurately and timely in tracking databases.Prepare, set up, and maintain local country study files and filing processes per applicable SOPs.Maintain knowledge and understanding of SOPs, directives, and current regulatory guidelines relevant to services provided.Requirements: Bachelor’s degree.Effective oral and written communication skills.Excellent interpersonal skills.Strong attention to detail and quality of documentation.Good negotiation skills.Good computer skills and ability to learn relevant software.Proficient English language and grammar skills.Basic knowledge of medical/therapeutic areas and medical terminology.Ability to work independently or in a team environment under direction, as required.Basic organizational and planning skills.Basic knowledge of applicable regional/national country regulatory guidelines and EC regulations.If you are interested in finding out more about this role or others, please contact Sharleney Chandraratna at schandraratna@ or call: +44 (0) 2075510732
Job Title
Country Approval Specialist