PbWant to know more? /b /ppbr/ppINSUD PHARMA operates across the entire pharmaceutical value chain, providing specialized knowledge and experience in scientific research, development, manufacturing, sales, and marketing of a wide range of active pharmaceutical ingredients (API), finished dosage forms (FDF), and branded pharmaceutical products, adding value to human and animal health. /ppbr/ppThe activities of INSUD PHARMA are organized into three synergistic business areas: Industrial (Chemo), Branded (Exeltis), and Biotech (mAbxience), with over 9,000 professionals in more than 50 countries, 20 state-of-the-art facilities, 15 specialized RD centers, 12 commercial offices, and more than 35 pharmaceutical subsidiaries, serving 1,150 customers in 96 countries worldwide. INSUD PHARMA believes in innovation and sustainable development. /ppbr/ppbReady to be a #Challenger? /b /ppbr/ppbr/ppbWhat are we looking for? /b /ppbr/ppWe are incorporating a new INSUDER as bRegulatory Affairs Associate /b at our plant in León. /ppbr/ppbThe Challenge! /b /ppbr/pulliUnderstand the needs of each customers and project and align them with the strategic guidelines of Chemo. /liliTo stay updated on changes in legislation and regulations and advises and gives interpretation on the potential impact to the product registration, marketing, manufacturing or development. /liliTo advice RD team on Regulatory requirements for registration dossier. /liliCompilation of required information for registration dossiers and for notifications (pharmaceutical products, food supplements and cosmetics) /liliRegistration submission and follow up with Health Authorities and Licensees, until product approval and launch. /liliCoordinate the submission and the approval for the Free Sales Certificates. /liliCoordination and preparation of Answers to deficiencies letters received from Health Authorities. /liliMaintains regulatory files/database and chronologies in good order. Establish and maintain system for tracking changes in documents submitted to agencies or licensees. /liliReviews product labelling for compliance with regulatory requirements. /liliReview and advice on product changes for impact on regulatory filings worldwide. /liliTechnical support to the sales department with the technical requirements of the customers. /liliServes as regulatory liaison throughout product lifecycle. /li /ulpbr/ppbWhat do you need? /b /ppbr/pulliEducation: Degree in Pharmacy, Chemistry or Biology. Master is a plus. /liliLanguages: Fluent Spanish and English, knowledge of other languages will be an asset. /liliExperience (years/area): 1 year of experiencie /liliSpecific Knowledge: Very good knowledge of general pharmaceutical legislation and regulations, including GMP. Experience with standard software tools (Word, Excel, PowerPoint, Project, etc.). /li /ulpbr/ppbOur benefits! /b /ppbr/pp Attractive salary package. /pp Permanent Contract. Full time from Monday to Friday /p