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 with 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.
Main Responsibilities:
1. Stay updated on changes in legislation and regulations and advise on the potential impact to the product registration, marketing, manufacturing or development.
2. Participate in the product development and regulatory strategy of new products.
3. Prepare, review and approve protocols and reports from CMOs or CROs.
4. Compile required information for registration dossiers and variations according to European legislation.
5. Submit registration and follow up with Health Authorities until product approval and launch.
6. Coordinate and prepare answers to deficiency letters received from Health Authorities.
7. Maintain regulatory files/database and chronologies in good order.
8. Establish and maintain a system for tracking changes in documents submitted to agencies.
Qualifications:
1. Education: University Degree in life sciences (Veterinary, Pharmacy, Chemistry or Biology). Master is a plus.
2. Languages: High level of English is a must; knowledge of other European languages is also a plus.
3. Experience: Minimum 2 years of experience required.
4. 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.).
5. Travels: Occasionally.
6. Personal skills: Good communication skills, teamwork, results-oriented, autonomous, creative, and entrepreneurial.
#J-18808-Ljbffr