Senior Regional Dossier Publisher – LATAM

About the role

The Regional Dossier Publisher (RDP) will work within Merck’s Global Regulatory Affairs and Clinical Safety organization, supporting publishing activities for the LATAM region. The role ensures regulatory submissions are assembled, validated and delivered to country regulatory affairs teams and health authorities on schedule.

Key responsibilities

• Identify, maintain and apply regional dossier assembly requirements, including structure, formats and delivery methods.
• Execute assembly and delivery processes to meet critical submission targets, acting as the regional technical expert for electronic submissions and agency gateways.
• Provide training and support to Country RA teams on publishing procedures and tools.
• Collaborate with the central publishing team to align processes, tools and standards across the region.
• Lead technical impact assessments and ensure readiness of publishing systems, validation tools and media creation.

Required profile

• Bachelor’s degree in Life Sciences, Pharmacy, Engineering or IT with pharmaceutical industry experience.
• At least 4 years of pharmaceutical experience, including 2 years in regulatory operations or affairs.
• Advanced English proficiency (B2+/C1).

Required skills

• Experience with Liquent Insight Publisher or similar publishing tools.
• Proficiency in MS Office applications, Adobe Acrobat, MS Project.
• Knowledge of Documentum/OpenText Documentum for document management.