Associate - Regulatory Affairs
Core
Manage and maintain regulatory data within the EMA Article 57 (A57) database, ensuring compliance with IDMP standards and supporting electronic submissions to the European Medicines Agency.
Role type
Associate Regulatory Affairs Specialist (IDMP/A57 Data Management)
Builds
Regulatory data submissions and compliance reports for pharmaceutical and medical device partners
Domain
Life Sciences / Regulatory Affairs / EU Medicines Agency
Required skills
A57 database management, IDMP compliance, RIMS, SPOR data management, EU regulatory requirements knowledge, data validation, quality control
Preferred skills
xEVMPD experience, pharmaceutical lifecycle management, regulatory submission tools
Technologies
EMA A57 database, RIMS, SPOR
Responsibilities
Manage and maintain regulatory data within the EMA Article 57 (A57) database; Ensure compliance with IDMP standards; Support electronic submission of regulatory data to EMA; Collaborate with cross-functional teams for data consistency; Assist in mapping and transformation of medicinal product data; Monitor updates to EMA IDMP guidelines; Provide data validation and quality control; Support EU shift operations including data entry and reporting; Coordinate with stakeholders to resolve data queries.
Seniority
Associate, 0–2 years experience