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Descripcion del trabajo
Who we are?
Veterinary 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.
In Vetpharma we are a highly qualified team.
We have extensive experience in development, registration and marketing veterinary medicinal products, APIs, 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.
Main Responsibilities :
* Stay updated on changes in legislation and regulations; advise and interpret their potential impact on product registration, marketing, manufacturing, or development.
* Participate in product development and regulatory strategy of new products.
* Prepare, review, and approve protocols and reports from CMOs or CROs.
* Compile required information for registration dossiers and variations according to European legislation.
* Handle registration submissions and follow up with health authorities until product approval and launch.
* Coordinate and prepare responses to deficiency letters from health authorities.
* Maintain regulatory files, databases, and document change tracking systems.
Qualifications :
* Education: University Degree in life sciences (Veterinary, Pharmacy, Chemistry, or Biology). A Masters degree is a plus.
* Languages: High level of English is required; knowledge of other European languages is a plus.
* Experience: Minimum 2 years in relevant area.
* Specific Knowledge: Good understanding of pharmaceutical legislation, regulations, and dossier formats. Proficiency with standard software tools (Word, Excel, PowerPoint, Project, etc.).
* Travel: Occasional travel required.
* Personal Skills: Good communication, teamwork, results oriented, autonomous, creative, entrepreneurial.
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