Regulatory Data Manager

Location: Escazu, Costa Rica; other locations: Bogota, Colombia, or Mexico City, Mexico

Employment type: Full time

Company

hirify.global develops medicines and manages global pharmaceutical products through regulated research, development, manufacturing, and commercial processes.

What you will do

• Manage regulatory information management events, registration records, event details, change items, label concepts, and global content plans.
• Review health authority communications, perform system impact assessments, and create activities, regulatory objectives, submissions, and related records.
• Maintain accurate and complete product registration data, active dossiers, submission statuses, deliverables, and regulatory metadata throughout the product lifecycle.
• Coordinate with GRS stakeholders, CMC product strategists, labeling leads, clinical and country regulatory strategists, IT, and cross-functional teams.
• Train business users, provide subject matter expertise, generate data-quality reports, and lead data review and update meetings.
• Lead or co-lead moderately complex projects and drive process, system, service, and operational improvements.

Requirements

• Bachelor’s or Master’s degree in Life Sciences, Regulatory Affairs, Data Management, or a related field.
• At least 4 years of experience in Regulatory Affairs or Regulatory Operations, including 3 or more years in data governance, data management, or data quality.
• Experience managing product and registration information, regulatory change management, impact assessments, health authority submissions, decisions, queries, interactions, and commitments.
• Detailed understanding of regulatory system structures, dossier maintenance, submissions, centralized registration procedures, IDMP, CMC, artwork, and labeling processes.
• Strong knowledge of data governance, master data management, and data quality improvement, with the ability to learn new software, regulations, and quality standards.
• Strong communication, collaboration, analytical, decision-making, and attention-to-detail skills.

Culture & Benefits

• Work across matrixed teams and collaborate with business units, IT, regulatory strategists, and global stakeholders.
• Contribute to continuous improvement initiatives focused on efficiency, quality, and operational excellence.
• Support business users through training, guidance, and advanced knowledge of regulatory systems and processes.