Associate - Regulatory Affairs

About the role

Associate - Regulatory Affairs at ClinChoice. Manage and maintain regulatory data within the EMA Article 57 (A57) database.

What you'll do

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

What you need

• 0–2 yrs of experience
• Regulatory affairs
• Quality control
• Communication
• Any graduate