Senior Specialist Regulatory Operations (electronic Submissions)

Alphapharm Pty Ltd T/A Viatris

Northern Cross, Ireland
Ectd requirements for multiple health authorities
Ms office, adobe acrobat professional
Document management systems (dms)
Viatris empowers people worldwide to live healthier at every stage of life through access, leadership, and partnership

Job Summary

  • Viatris empowers people worldwide to live healthier at every stage of life through access, leadership, and partnership.
  • The Senior Specialist will support end-to-end publishing and submission of regulatory dossiers in electronic format, performing quality control, validation, and transmission.
  • Viatris offers competitive salaries, benefits, and an inclusive environment with a focus on career progression, health and wellness, and volunteer days.

Matching Summary

Viatris empowers people worldwide to live healthier at every stage of life through access, leadership, and partnership.

Skills & Requirements

Must-have

  • eCTD requirements for multiple Health Authorities
  • MS Office, Adobe Acrobat Professional
  • Document Management Systems (DMS)
  • eCTD Publishing software
  • registrations management systems
  • publishing and dossier submission management

Nice-to-have

  • independent, proactive, and results-oriented work style
  • ability to collaborate in cross-functional teams
  • demonstrated ability to quickly learn new technology
  • mentoring junior colleagues

Key Requirements

  • Bachelor’s degree with focus on Information Management, Bio Science, Business Administration or equivalent
  • Profound knowledge in the regulatory operations sector
  • Expert knowledge of eCTD requirements
  • Expertise with MS Office, Adobe Acrobat Professional, DMS, eCTD Publishing software, and RIM systems
  • Very good command of written and spoken English
  • Ability to multi-task and manage multiple projects and deadlines
  • Ability to work in a fast paced environment
  • Excellent attention to detail and propensity to learn

Work Rights

Not specified

Tailored Resume

Cover Letter