Senior Regulatory Submissions Specialist – eCTD Expert

1100 Mylan Pharmaceuticals Inc.; Lisboa; Híbrido; EUR 42 000 - 62 000; Tempo integral

Resumo da oferta

Viatris is seeking a Senior Specialist, Regulatory Operations (Electronic Submissions) in Lisbon to manage end-to-end publishing and submission of regulatory dossiers in electronic formats. You will ensure QC, validate submissions, and oversee schedules with global coordination.

The role requires expertise in eCTD, DMS systems, and publishing software, plus strong English skills and the ability to work in a fast-paced, cross-functional environment.

Qualificações

• Bachelor’s degree or equivalent in Information Management, Bio Science, or Business Admin.
• Expert knowledge of regulatory publishing and dossier submission processes.
• Strong command of eCTD requirements across Health Authorities.
• Experience with DMS, MS Office, Adobe Acrobat, and eCTD tools.
• Excellent English, detail-oriented, and able to manage multiple projects.

Responsabilidades

• Publish, transmit, and archive regulatory submissions in eCTD or non-eCTD formats.
• Perform QC and technical validation of submissions before internal review.
• Manage global publishing schedules and team workload.
• Serve as SME for publishing queries across Regulatory Affairs.
• Develop and maintain internal guidelines and training materials.
• Mentor junior colleagues in publishing practices and software use.
• Act as backup for management and coordinate team workload.

Conhecimentos

Regulatory operations

eCTD knowledge

Publishing software

Project management

English proficiency

Formação académica

Bachelor’s degree or equivalent

Ferramentas

MS Office

Adobe Acrobat Pro

DMS

eCTD publishing software

Descrição da oferta de emprego

Viatris is seeking a Senior Specialist, Regulatory Operations (Electronic Submissions) in Lisbon to manage end-to-end publishing and submission of regulatory dossiers in electronic formats. You will ensure QC, validate submissions, and oversee schedules with global coordination.

The role requires expertise in eCTD, DMS systems, and publishing software, plus strong English skills and the ability to work in a fast-paced, cross-functional environment.