Regulatory Submissions Lead — eCTD & Publishing Expert

Viatris; Lisboa; Presencial; EUR 45 000 - 65 000; Tempo integral

Vantagens oferecidas por esta oferta de emprego

Top Employer Accreditation

Competitive compensation package

Health & Wellness programmes

100% paid medical insurance

Life cover

Employer-matched pension (11%)

2 paid volunteer days

Resumo da oferta

Viatris seeks a Senior Specialist, Electronic Submissions to support end-to-end publishing and submission of regulatory dossiers for new and existing products. You will ensure quality control, electronic transmission, and archiving, while mentoring junior colleagues and leading publishing activities.

This international role requires strong English communication, expertise in eCTD, and the ability to coordinate with Regulatory Affairs and cross-functional teams.

Qualificações

• Bachelor’s degree with focus on Information Management, Bio Science, Business Administration or equivalent preferred.
• Profound knowledge in regulatory operations, especially publishing and dossier submission management.
• Expert knowledge of eCTD requirements for multiple Health Authorities.
• Proficiency with MS Office, Adobe Acrobat Pro, DMS, eCTD publishing software and related systems.
• Excellent written and spoken English.

Responsabilidades

• Publish, transmit, and archive MA applications and maintenance submissions in eCTD or non-eCTD formats, to meet deadlines and SLAs.
• Perform QC and technical validation of electronic submissions.
• Manage and monitor publishing schedules; provide workload summaries.
• Serve as SME for publishing queries across Regulatory Affairs and cross-functional teams.
• Contribute to creation, maintenance, and training of internal system guidelines.

Conhecimentos

English (written and spoken)

Multi-tasking

Independent and proactive

Results-oriented

Formação académica

Bachelor’s degree (Information Management/Bio Science/Business Admin)

Ferramentas

MS Office

Adobe Acrobat Pro

DMS

eCTD Publishing software

Registrations management systems

Descrição da oferta de emprego

Viatris seeks a Senior Specialist, Electronic Submissions to support end-to-end publishing and submission of regulatory dossiers for new and existing products. You will ensure quality control, electronic transmission, and archiving, while mentoring junior colleagues and leading publishing activities.

This international role requires strong English communication, expertise in eCTD, and the ability to coordinate with Regulatory Affairs and cross-functional teams.