Senior Specialist Regulatory Operations (Electronic Submissions), Dublin Pike

Senior Specialist, Electronic Submissions Our mission is to empower people worldwide to live healthier at every stage of life. We are looking for a Senior Specialist, Electronic Submissions to join our regulatory operations team. The role involves end‑to‑end publishing and submission of regulatory dossiers in electronic format, ensuring quality control and regulatory compliance.

Responsibilities

Publish, transmit, and archive Marketing (MA) Applications and maintenance submissions in eCTD or non‑eCTD formats for new and existing products, meeting deadlines and Service Level Agreements.

Perform QC and technical validation of electronic submissions to ensure compliance with internal standards and external criteria before delivery to Regulatory Users for review/approval.

Manage and monitor publishing schedules, coordinate global support during resource constraints, and provide workload and project summaries at team meetings or to leadership.

Serve as the primary contact and subject‑matter expert for publishing queries across Regulatory Affairs and cross‑functional disciplines.

Contribute to the creation, maintenance, and training of internal regulatory system guidelines within scope of this role.

Develop and maintain an advanced working knowledge of publishing software and other regulatory systems.

Mentor junior colleagues in publishing practices, workload management and software system use.

Act as a backup for management in their absence, including coordination of workload for the team, meeting attendance and answering queries.

Qualifications

Bachelor’s degree focused on Information Management, Bio Science, Business Administration or equivalent preferred; a combination of experience and/or education will be considered.

Profound knowledge in regulatory operations, especially in publishing and dossier submission management.

Expertise with eCTD requirements for multiple Health Authorities.

Advanced proficiency with MS Office, Adobe Acrobat Professional, Document Management Systems (DMS), eCTD publishing software and registration management systems.

Strong command of written and spoken English.

Ability to multi‑task, manage multiple projects and deadlines in a fast‑paced environment, with excellent attention to detail and a proactive, results‑oriented work style.

Benefits

Top Employer Accreditation.

Competitive compensation package.

Career progression with growth and development opportunities.

Health&Wellness programmes.

100% paid medical insurance and Employee Assistance Programme.

Life cover.

Employer‑matched pension scheme with up to 11% contribution.

2 paid volunteer days per year.

Viatris is an Equal Opportunity Employer.

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