Senior eCTD Submissions Specialist | Regulatory Operations

Viatris; Almada; On-site; EUR 65,000 - 90,000; Full time

Job summary

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.

Qualifications

• Experience with eCTD submissions and regulatory publishing.
• Ability to coordinate global teams and meet timelines.

Responsibilities

• Manage eCTD submissions and QC.
• Maintain publishing schedules and timelines.
• Mentor junior colleagues and act as SME across Regulatory Affairs.

Job description

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.