Regulatory Affairs Associate

Who we are?Compruebe a continuación si tiene lo necesario para esta oportunidad y, si es así, envíe su solicitud lo antes posible.Veterinary medicine manufacturersVetpharma 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.In Vetpharma we are a highly qualified team.We have extensive experience in development, registration and marketing veterinary medicinal products, API’s and nutraceuticals.Overview: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.Responsabilities:To 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.Participate in the product development and regulatory strategy of the new products.Prepare, review and approve protocols and reports from CMOs or CROs.Compilation of required information for registration dossiers and variations according to European legislation.Registration submission and follow up with Health Authorities until product approval and launch.Coordination and preparation of Answers to deficiencies letters received from Health Authorities.Maintains regulatory files/database and chronologies in good order. Establish and maintain system for tracking changes in documents submitted to agencies.Qualifications:Education: University Degree in life sciences (Veterinary, Pharmacy, Chemistry or Biology). Master is a plus.Languages: High level of English is a must; Knowledge of other European language is also a plus.Experience (years/area): minimum 2 years of experience required.Specific Knowledge: Very good knowledge of general pharmaceutical legislation and regulations and registration dossier format content. Proficiency with standard software tools (Word, Excel, PowerPoint, Project, etc.).Travels: OccasionallyPersonal skills: good communication skills, teamwork, results-oriented, autonomous, creative, and entrepreneurialOur benefits Flexible start time from Monday to Friday (full-time). Permanent contract. Life and accident insurance. Ticket restaurant Benefits and Savings Club. Training and language learning platform Wellness platform with unlimited free psychologist sessions Cabify transportation service for employee use Development plans, internal mobility policy. Many moreWhat will the Selection process be like? Stay tuned to your phone and email The first thing we will likely do is contact you through one of the two channels. Prepare well We will continue with an in-person/virtual interview depending on availability and what we agree upon; there may be one or two interviews in the process, and depending on the type of process, there may also be some kind of test. Wait for the result We care that you feel guided throughout each selection process and know what to expect from us, so we will always try to inform you of the status of the process. Do you think this offer is not for you? Follow us on social media like LinkedIn/Instagram and stay tuned for any offers we may release; the opportunity to be a new Insuder is waiting xsgfvud #InsudPharma #Challenger #Insuder #InsudTalentCOMMITMENT TO EQUAL OPPORTUNITIESThe InsudPharma 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.