Senior Specialist Regulatory Operations (Electronic Submissions)

About the role

Viatris is hiring a Senior Specialist Regulatory Operations (Electronic Submissions) in Lisbon. The role supports, with minimal supervision, the end-to-end publishing and submission of regulatory dossiers for new and existing products in electronic format, covering quality control, validation, electronic transmission and archiving. It is a senior position acting as subject matter expert and mentor to junior colleagues.

Key responsibilities

• Publish, transmit and archive Marketing (MA) applications and maintenance submissions in eCTD or non-eCTD formats, meeting deadlines and service level agreements.
• Perform quality control and technical validation of electronic submissions before they go to Regulatory Affairs for approval.
• Manage publishing schedules, coordinate global support during resource constraints and share workload and project summaries with leadership.
• Serve as the main contact and subject matter expert for publishing queries across Regulatory Affairs and other functions.
• Help create, maintain and train internal regulatory system guidelines, and mentor junior colleagues.
• Act as a backup for management in their absence, including workload coordination and meeting attendance.

Required profile

• Bachelor's degree in Information Management, Bio Science, Business Administration or equivalent preferred; experience and/or education will also be considered.
• Profound knowledge of regulatory operations, especially publishing and dossier submission management.
• Expert knowledge of eCTD requirements for multiple health authorities.
• Very good command of written and spoken English.
• Ability to multi-task, work in a fast-paced environment, pay close attention to detail and learn quickly.

Required skills

• MS Office and Adobe Acrobat Professional.
• Document management systems (DMS) and eCTD publishing software.
• Registrations management systems and associated global publishing processes and regulations.

What we offer

• Competitive salary and benefits, including 100% paid medical insurance and employee assistance programme.
• Life cover and an employer-matched pension scheme (up to 11%).
• Career progression, health and wellness programmes and two paid volunteer days per year.