Regulatory Affairs Associate

hace 6 días

Cádiz, Cádiz, España Vetpharma A tiempo completo

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, 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.

Main Responsibilities :

  • 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 : Occasionally
  • Personal skills : good communication skills, teamwork, results-oriented, autonomous, creative, and entrepreneurial.
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