Work ScheduleControlli attentamente tutta la documentazione richiesta per la candidatura prima di fare clic sul pulsante apposito in fondo a questa descrizione.Standard (Mon-Fri)Environmental ConditionsOfficeJob DescriptionJoin us as a Country Approval Specialist and make an impact at the forefront of innovation.
We have successfully supported the top 50 pharmaceutical companies and more than 750 biotechs, spanning 2,700 clinical trials across 100+ countries in the last 5 years.
As part of our global team, you'll have the opportunity to participate in the management and preparation, review, and coordination of Country Submissions in line with the global submission strategy.
As a Country Approval Specialist, you'll play a key role in ensuring that submissions are managed effectively and align with our strategic goals.What you will do:Prepare, review and coordinate local regulatory submissions (MoH, EC, additional special national local applications if applicable, e.G. gene therapy approvals, viral safety dossiers, import license) in alignment with EU/global submission strategyProvide local regulatory strategy advice (MoH &/or EC) to internal clientsProvide project specific local start-up services and coordination of these projectsMay have contact with investigators for submission related activitiesServe as key-contact at country level for either Ethical or Regulatory submission-related activitiesCoordinate with internal functional departments to ensure various site start-up activities are aligned with submissions activities and mutually agreed upon timelines; ensure alignment of submission process for sites and study are aligned to the critical path for site activationAchieve target cycle times for site activationPrepare the regulatory compliance review packages, if applicableDevelop country specific Patient Information Sheet/Informed Consent form documentsMay assist with grant budget(s)



and payment schedules negotiations with sitesMay support the feasibility activities, as required, in accordance with agreed timelinesEnter and maintain trial status information relating to start-up activities onto the study specific tracking databases in an accurate and timely mannerEnsure the local country study files and filing processes are prepared, set up and maintained as per applicable SOPsMaintain knowledge of and understand SOPs, client directives, and current regulatory guidelines as applicable to services providedEducation and experience:Bachelor's degree or equivalent and relevant formal academic/vocational qualificationPrevious experience that provides the knowledge, skills, and abilities to perform the job (comparable to 2+ years)In some cases an equivalency, consisting of a combination of appropriate education, training and/or directly related experience, will be considered sufficient for an individual to meet the requirements of the roleKnowledge, skills and abilities:Effective oral and written communication skillsExcellent interpersonal skills xysqume Strong attention to detail and quality of documentationGood negotiation skillsGood computer skills and the ability to learn appropriate softwareGood English language and grammar skillsBasic medical/therapeutic area and medical terminology knowledgeAbility to work in a team environment or independently, under direction, as requiredBasic organizational and planning skillsBasic knowledge of all applicable regional/national country regulatory guidelines and EC regulationsWorking conditions and environment:Work is performed in an office environmentExposure to electrical office equipmentThermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.
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📌 Fsp Country Approval Specialist (Lazio)
🏢 Thermofisher Scientific
📍 Lazio