Associate - Regulatory Affairs

📋 Description

• Manage and maintain regulatory data within the EMA Article 57 (A57) database
• Ensure compliance with IDMP (Identification of Medicinal Products) standards and evolving
• Support the electronic submission of regulatory data to EMA (European Medicines Agency)
• Collaborate with cross-functional teams, including Regulatory Affairs, IT, and Compliance, to
• Assist in the mapping and transformation of medicinal product data to meet IDMP standards
• Monitor updates and changes to EMA's IDMP implementation guidelines and ensure adherence

🎯 Requirements

• Bachelor's/Master's degree in Life Sciences, Pharmacy, Regulatory Affairs, or a related field
• Experience in A57 database management and IDMP compliance
• Knowledge of Regulatory Information Management Systems (RIMS) and structured data submissions
• Familiarity with SPOR (Substance, Product, Organization, and Referential) data management
• Strong understanding of EU regulatory requirements and EMA guidelines
• Proficiency in data handling, validation, and quality control

🎁 Benefits

• Work on high-impact regulatory projects in a global environment
• Opportunity to develop expertise in IDMP compliance and data management
• Collaborate with industry experts and enhance your regulatory knowledge