Regulatory affairs associate (La Línea de la Concepción)
3 days ago
La Línea de la Concepción
ppVeterinary medicine manufacturers Vetpharma is the veterinary division of Chemo, part of the Insud Pharma group, providing Animal Health solutions. We are located in Barcelona, where the group was founded in 1977. We have extensive experience in development, registration and marketing veterinary medicinal products, API's and nutraceuticals. /ppOverview: Compiles and manages the Registration dossier or the Variation packages and coordinates the submission and follow up until product approval and launch or change implementation. Organizes regulatory information, logs and tracking. Active participation in product development. /ph3Responsibilities /h3ulliStay updated on changes in legislation and regulations and advise on potential impact to product registration, marketing, manufacturing or development. /liliParticipate in product development and regulatory strategy of new products. /liliPrepare, review and approve protocols and reports from CMOs or CROs. /liliCompile required information for registration dossiers and variations according to European legislation. /liliSubmit registration and follow up with Health Authorities until product approval and launch. /liliCoordinate and prepare answers to deficiencies letters received from Health Authorities. /liliMaintain regulatory files/database and chronologies in good order. /liliEstablish and maintain a system for tracking changes in documents submitted to agencies. /li /ulh3Qualifications /h3ulliEducation: University Degree in life sciences (Veterinary, Pharmacy, Chemistry or Biology). Master’s degree is a plus. /liliLanguages: High level of English is a must; knowledge of other European languages is a plus. /liliExperience: minimum 2 years of experience in relevant field. /liliSpecific Knowledge: Very good knowledge of general pharmaceutical legislation and regulations, and registration dossier format content. /liliProficiency with standard software tools (Word, Excel, PowerPoint, Project, etc.). /liliTravels: Occasionally. /liliPersonal skills: good communication, teamwork, results‑oriented, autonomous, creative, and entrepreneurial. /li /ulh3Benefits /h3ulliPermanent contract. /liliLife and accident insurance. /liliTicket restaurant. /liliBenefits and Savings Club. /liliTraining and language learning platform. /liliWellness platform with unlimited free psychologist sessions. /liliCabify transportation service for employee use. /liliDevelopment plans, internal mobility policy. /liliVersatile start time from Monday to Friday (full‑time). /li /ulh3Equal Opportunities /h3pThe Insud Pharma group is aware that business management must align with the needs and demands of society, and therefore assumes the commitment to equal opportunities and treatment between men and women, as stated in the current regulations on the matter. Organic Law 3/2007, and we do not discriminate against any person on the grounds of ethnicity, religion, age, sex, nationality, marital status, affective or sexual orientation, gender identity or expression, disability, or any other personal or social circumstance. /p /p #J-18808-Ljbffr