Senior Regulatory Affairs Specialist – Latin America

About the role

The Regulatory Submissions Planner is part of the Regional Regulatory Operations team within the Global Regulatory Affairs and Clinical Safety organization. The role supports the preparation of regulatory submissions and manages registration tracking to ensure alignment with strategic target dates across Latin America.

Key responsibilities

• Plan, coordinate and review regulatory submissions for release to Country Operations teams or Health Authorities.
• Develop and maintain the regulatory submission plan and related project milestones for assigned products.
• Attend and contribute to planning forums and cross‑functional meetings.
• Drive submission assembly and delivery with the Regional Publisher or Global Submission Publishing team.
• Access and maintain regulatory systems and databases for daily functions.
• Identify opportunities for process improvement and participate in small‑scale improvement projects.
• Maintain up‑to‑date knowledge of LATAM registration procedures and internal/external guidelines.

Required profile

• Bachelor’s degree in Life Science, Engineering or related discipline; Pharmacy degree preferred.
• Experience in Regulatory Operations or Regulatory Affairs within the pharmaceutical industry.
• Proven project‑management skills with ability to manage multiple priorities and dynamic timelines.
• Thorough knowledge of regulatory guidelines and procedures in the Latin America region.
• Excellent communication skills for interaction in a multicultural environment.
• Ability to work effectively under time pressure and handle complex IT systems.

Required skills

• Microsoft Excel
• Microsoft Teams
• Microsoft PowerPoint
• Microsoft SharePoint