Sr Specialist Regulatory Affairs
Core
Plan, coordinate, and execute regulatory submissions for pharmaceutical products to Health Authorities across Latin America, ensuring alignment with strategic target dates.
Role type
Senior Regulatory Submissions Planner (Regulatory Operations)
Builds
Regulatory dossiers and submissions for Health Authorities in LATAM
Domain
Pharmaceutical industry, Latin American regulatory landscape
Deliverable
client delivery
Required skills
Regulatory operations, submission planning, project management, stakeholder coordination, regulatory compliance, process improvement, database management, Latin American regulatory knowledge
Preferred skills
Pharmacy degree, Microsoft Excel, Microsoft PowerPoint, Microsoft SharePoint, operational excellence, stakeholder engagement
Technologies
Microsoft Office (Excel, PowerPoint, SharePoint), regulatory systems and databases
Responsibilities
Develop and maintain regulatory submission plans and project milestones; coordinate submission review and release to Country Operations; drive submission assembly and delivery with the Regional Publisher; maintain regulatory systems and databases; identify process improvement opportunities; maintain knowledge of LATAM regulatory procedures
Seniority
Senior, hands-on IC
