Director, Regulatory CMC Sciences & Project Leadership

Viatris; Dublin; On-site; EUR 150,000 - 190,000; Full time

Benefits offered by this job

Excellent career progression

Work-life balance initiatives

Bonus scheme

Health insurance

Pension

Job summary

Viatris is seeking a Director Regulatory CMC Sciences Project Management in Ireland to lead global, complex post-approval change programs and site transfers. You will drive regulatory strategy, coordinate cross-functional teams, and manage large-scale projects from planning to submission.

The role requires hands-on CMC authoring and strong leadership within a matrixed organization. Join Viatris to contribute to global healthcare access, with opportunities for mentorship, dashboards of regulatory

Qualifications

• Hands-on CMC authoring experience (registrations or post-approval variations).
• Proven capability in managing complex regulatory projects with PM tools.
• Extensive knowledge of post-approval variations for site transfers and alternate API sourcing.
• Knowledge of current and emerging regulatory requirements and global submission expectations.

Responsibilities

• Provide regulatory project management for global, large-scale, complex network projects.
• Coordinate priorities across multiple projects; develop tools for submission planning and forecasting timing.
• Lead team oversight for contracted GRA resources.
• Collaborate with Ops, R&D, Quality, Sourcing to guide regulatory assessments for site transfers and sourcing.
• Develop and maintain regulatory strategies and mitigation plans.
• Create dashboards and metrics for stakeholder reporting.
• Serve as the internal single point of contact for a broad project portfolio.

Skills

Regulatory project management

Regulatory strategy

Communication skills (written & oral)

Cross-functional collaboration

Leadership of matrixed teams

Submission planning & forecasting

Stakeholder management

Problem solving / risk mitigation

Strategic thinking

Mentoring colleagues

Tools

Microsoft Office Suite

Documentum-based applications

Job description

Viatris is seeking a Director Regulatory CMC Sciences Project Management in Ireland to lead global, complex post-approval change programs and site transfers. You will drive regulatory strategy, coordinate cross-functional teams, and manage large-scale projects from planning to submission.

The role requires hands-on CMC authoring and strong leadership within a matrixed organization. Join Viatris to contribute to global healthcare access, with opportunities for mentorship, dashboards of regulatory