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REGULATORY ASSOCIATE

Descripción de la oferta de empleo

We are hiring an experienced Regulatory Associate to join our team in Italy, candidates can be based anywhere in Spain.Position SummaryTo assume regulatory responsibilities including initial and subsequent Clinical Trial submissions to Competent Authority (CA) and Ethics Committees (ECs) in the assigned country(ies) and ensure compliance with local and international clinical trials regulations and guidelines.Essential functions of the job include but are not limited to:Keep an updated knowledge of the local clinical trial laws, regulations and guidelines to perform the assigned regulatoryPreparation of Clinical Trial Application Forms (Country EudraCT form for EEA countries and/or National Application Form).Preparation of submission dossier (initial and amendments/notifications) for submission to CA, EC and other applicable local bodies according to local requirements and within required timelines to obtain all necessary authorisations/approvals for the conduct of the ClinicalInteraction with CA/EC for study purposes and handling responses to the CA/EC.Providing CA/EC related information asProviding regular updates about CA and EC submissions to Vice President Regulatory/Designee, to the responsible person coordinating the submissions, to Clinical Project Manager and to the responsible LeadParticipating in regulatory activities within the company and ensuring regulatory (CA and EC) related activities are performed according to international and local/national applicable regulations, company SOPs and principles of ICH-GCP.Regular attendance to RegulatoryAssisting training of CRAs (if applicable) to ensure they have the necessary knowledge for preparation of the clinical documents required for the regulatory submissions.Assuming other regulatory responsibilities if required and upon the request of Director, Regulatory/ VP, Regulatory.Qualifications/ExperienceMedical/science background and /or relevant experiencePrior clinical research and regulatory submissions experienceFluent in Spanish and EnglishComputer literacyGood communication skillsGood interpersonal skillsPrecision for Medicine is a precision medicine CRO. Precision’s uniquely integrated offering enables the science of precision medicine by combining novel clinical trial designs, industry-leading operational and medical experts, advanced biomarker and data analytics solutions, and an unequivocal real passion for n ovel therapeutics in various indications.Any data provided as a part of this application will be stored in accordance with our Privacy Policy .Precision Medicine Group is an Equal Opportunity Employer. Employment decisions are made without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status or other characteristics protected by law. © 2020 Precision Medicine Group, LLCIf you are an individual with a disability and require a reasonable accommodation to complete any part of the application process, or are limited in the ability or unable to access or use this online application process and need an alternative method for applying, you may contact Precision Medicine Group at QuestionForHR@precisionmedicinegrp.com .
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Detalles de la oferta

Empresa
  • Precision Medicine Group
Localidad
  • En toda España
Dirección
  • Sin especificar - Sin especificar
Fecha de publicación
  • 04/08/2022
Fecha de expiración
  • 02/11/2022
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