Regional Dossier Publisher, Sr Specialist
Core
Regional expert responsible for assembling, validating, and delivering regulatory dossiers to health authorities in the LATAM region, ensuring compliance with local and global standards.
Role type
Senior Regulatory Operations Specialist (Dossier Publishing)
Builds
Regulatory submissions and dossiers for LATAM markets
Domain
Pharmaceutical Regulatory Affairs / Life Sciences
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work -> regulatory submissions
Required skills
Regulatory Operations, Dossier Assembly, Regulatory Compliance, LATAM Regulatory Procedures, Process Improvement, Technical Validation, Training Delivery, System Readiness, File Format Management, Electronic Submissions
Preferred skills
Liquent Insight Publisher, OpenText Documentum, Pharmacovigilance, MS Project, Adobe Acrobat
Technologies
Liquent Insight Publisher, OpenText Documentum, MS Office, Adobe Acrobat, MS Project
Responsibilities
Identify and maintain requirements for regulatory dossier assembly; execute assembly and delivery processes to meet submission targets; serve as technical expert for Country RA teams; lead technical impact assessments of regional requirements; provide training on publishing processes; support system testing and readiness; advocate for standardization across supported countries.
Seniority
Senior, hands-on IC