Senior Regional Dossier Publisher (LATAM)

About the role

The Regional Dossier Publisher (RDP) supports the Global Regulatory Affairs and Clinical Safety organization by managing regulatory dossier assembly and delivery for the LATAM region. The role ensures submissions meet local requirements and collaborates with both regional and headquarters publishing teams.

Key responsibilities

• Identify and maintain regional regulatory dossier assembly requirements, including structure, formats, and delivery methods.
• Execute assembly and delivery processes to meet critical submission deadlines.
• Provide technical expertise on dossier structures, electronic submissions, agency gateways, and repository systems.
• Support Country RA teams with training, technical guidance, and local publishing needs.
• Lead impact assessments of regional requirements and ensure system readiness for publishing activities.
• Collaborate with the Central Publishing Team to align global standards with regional specifics.

Required profile

• Bachelor’s degree in Life Sciences, Pharmacy, Engineering or IT with pharmaceutical experience.
• Minimum 4 years in the pharmaceutical industry, including at least 2 years in regulatory operations or affairs.
• Strong analytical, customer‑service, and communication skills.
• Ability to work under tight deadlines and attention to detail.

Required skills

• Liquent Insight Publisher (or similar publishing tools)
• Microsoft Office suite
• Adobe Acrobat
• Microsoft Project
• Documentum / OpenText Documentum