Director, Global Regulatory CMC Projects

1100 Mylan Pharmaceuticals Inc.; Dublin; On-site; EUR 150,000 - 210,000; Full time

Benefits offered by this job

Health insurance

Bonus scheme

Pension

Job summary

Viatris invites an experienced Director to lead regulatory CMC project management across global networks, focusing on large-scale site transfers and alternate API sourcing. You will coordinate multi-project priorities, mentor teams, and deliver robust submission packages with clear risk mitigation.

Advanced knowledge of post-approval variations, cGMPs, and regulatory strategies is essential, as is collaboration with senior stakeholders to drive timely, compliant outcomes.

Qualifications

• Hands-on CMC authoring experience (registrations or variations).
• Proven ability to manage complex regulatory projects.
• Strong knowledge of post-approval variations and site transfers.

Responsibilities

• Manage global, large-scale regulatory projects and site transfers.
• Coordinate priorities across multiple projects and teams.
• Develop submission plans, tracking, and timing forecasts.
• Lead contracted GRA resources and mentor colleagues.
• Communicate regulatory risks and mitigation progress.
• Generate dashboards and metrics for stakeholders.

Skills

Regulatory project management

CMC authoring

Cross-functional leadership

Stakeholder management

Dashboarding / reporting

Education

Bachelor’s or Master’s in life sciences

Tools

Microsoft Office

Documentum

Job description

Viatris invites an experienced Director to lead regulatory CMC project management across global networks, focusing on large-scale site transfers and alternate API sourcing. You will coordinate multi-project priorities, mentor teams, and deliver robust submission packages with clear risk mitigation.

Advanced knowledge of post-approval variations, cGMPs, and regulatory strategies is essential, as is collaboration with senior stakeholders to drive timely, compliant outcomes.