Strategic Leader — Brands Regulatory CMC Sciences

Viatris; Dublin; On-site; EUR 90,000 - 130,000; Full time

Job summary

Viatris is hiring a Manager, Brands Regulatory CMC Sciences to lead CMC regulatory strategies across global programs from their Dublin area. The role emphasizes hands-on CMC authoring, submissions, and cross-functional collaboration with R&D, Quality, and Regulatory leads.

The successful candidate will develop regulatory strategies, manage submission plans, and mentor teams while maintaining compliance with global regulations and internal policies.

Qualifications

• Hands-on CMC authoring experience (initial registrations or post-approval variations).
• Ability to shape regulatory strategies and lead project teams.
• Experience with regulatory submissions and quality compliance in global programs.

Responsibilities

• Develop robust CMC regulatory strategies for global programs.
• Prepare and deliver high-quality CMC regulatory submissions and plans.
• Mentor and guide project teams and engage with regulatory authorities as needed.

Skills

CMC authoring

Regulatory strategy

Project management

Regulatory submissions

Quality compliance

Tools

Microsoft Office

Documentum

Job description

Viatris is hiring a Manager, Brands Regulatory CMC Sciences to lead CMC regulatory strategies across global programs from their Dublin area. The role emphasizes hands-on CMC authoring, submissions, and cross-functional collaboration with R&D, Quality, and Regulatory leads.

The successful candidate will develop regulatory strategies, manage submission plans, and mentor teams while maintaining compliance with global regulations and internal policies.