Senior Regulatory Submissions Specialist

Viatris; Dublin; On-site; EUR 60,000 - 76,000; Full time

Benefits offered by this job

Career progression

Health insurance

Pension

Bonus scheme

Work-life balance

Job summary

Viatris is seeking a Regulatory Affairs Senior Specialist to join the GSM Team in Dublin. The role supports Global Submission Managers by planning submissions, troubleshooting issues, and maintaining quality standards.

You will prepare documents per Viatris formatting and agency requirements, QC outputs, and participate in continuous improvement projects. The ideal candidate will have computer literacy, strong written and spoken communication, and relevant experience in submissions.

Qualifications

• Educational background Computer Literacy with Microsoft Office Suite.
• Good Communication skills (written & oral).
• Relevant experience/skillset in regulatory submissions or GSM is desirable.

Responsibilities

• Assist in submission planning and scheduling within the GSM team.
• Prepare submission documents following Viatris formatting standards and agency requirements.
• QC of published output for technical conformance and fix validation issues as directed.
• Contribute to special projects and continuous improvement initiatives.

Skills

Communication skills

Computer literacy

Tools

Microsoft Office

Job description

Viatris is seeking a Regulatory Affairs Senior Specialist to join the GSM Team in Dublin. The role supports Global Submission Managers by planning submissions, troubleshooting issues, and maintaining quality standards.

You will prepare documents per Viatris formatting and agency requirements, QC outputs, and participate in continuous improvement projects. The ideal candidate will have computer literacy, strong written and spoken communication, and relevant experience in submissions.