Senior Regulatory Submissions Specialist - eCTD Expert

1100 Mylan Pharmaceuticals Inc.; Lisboa; Presencial; EUR 42 000 - 66 000; Tempo integral

Vantagens oferecidas por esta oferta de emprego

Medical insurance

Pension scheme

Volunteer days

Career progression

Resumo da oferta

Viatris in Lisbon, Portugal, seeks a Senior Specialist Regulatory Operations (Electronic Submissions) to support end-to-end publishing and submission of regulatory dossiers in electronic format. The role requires coordination with global teams and adherence to timelines.

With minimal supervision, you will manage eCTD submissions, perform QC, maintain publishing schedules, and mentor junior colleagues while acting as SME across Regulatory Affairs and related functions.

Qualificações

• Bachelor's degree with focus on Information Management, Bio Science, Business Administration or equivalent preferred.
• Profound knowledge in the regulatory operations sector, especially in publishing and dossier submission management.
• Must maintain expert knowledge of eCTD requirements for multiple Health Authorities.
• Expertise with MS Office, Adobe Acrobat Pro, Document Management Systems (DMS), eCTD Publishing software and registrations management systems and related regulations.
• Very good command of written and spoken English.

Responsabilidades

• Publish, transmit, and archive MA Applications and maintenance submissions in eCTD or non-eCTD formats.
• Perform QC and technical validation of electronic submissions.
• Manage and monitor publishing schedules and coordinate global support.

Conhecimentos

Regulatory operations knowledge

eCTD knowledge

English proficiency

Multi-tasking

Cross-functional collaboration

Mentoring

Formação académica

Bachelor's degree (Information Management / Bio Science / Business Administration)

Ferramentas

MS Office

Adobe Acrobat Pro

Document Management Systems

eCTD Publishing software

Regulatory systems

Descrição da oferta de emprego

Viatris in Lisbon, Portugal, seeks a Senior Specialist Regulatory Operations (Electronic Submissions) to support end-to-end publishing and submission of regulatory dossiers in electronic format. The role requires coordination with global teams and adherence to timelines.

With minimal supervision, you will manage eCTD submissions, perform QC, maintain publishing schedules, and mentor junior colleagues while acting as SME across Regulatory Affairs and related functions.