Global Regulatory Affairs Manager, Brands CMC

Viatris; Dublin; Remote; EUR 90,000 - 120,000; Full time

Benefits offered by this job

Health insurance

Bonus scheme

Pension

Career progression

Work-life balance

Job summary

Viatris in Dublin, Ireland seeks a Regulatory Affairs Manager, CMC who will lead global CMC regulatory strategies and author high-quality submissions. You will work with R&D, Manufacturing, Quality and Regulatory teams to ensure timely approvals across global markets.

The role emphasizes independent thinking, cross-functional collaboration, and mentoring junior staff while upholding rigorous scientific standards, compliance and lifecycle management for the Upjohn product portfolio.

Qualifications

• Hands-on CMC regulatory authoring experience.
• Strong knowledge of CMC regulatory requirements, pharmaceutical development, and cGMP principles.
• Experience supporting global regulatory submissions and lifecycle management activities.
• Proven ability to develop regulatory strategies and manage cross-functional projects.
• Excellent communication, stakeholder management, and problem-solving skills.

Responsibilities

• Lead the development and execution of global CMC regulatory strategies for pharmaceutical products.
• Prepare and manage high-quality CMC regulatory submissions for worldwide health authorities, including new registrations, post-approval changes, renewals, and lifecycle management activities.
• Act as the CMC Regulatory representative on cross-functional project teams, providing strategic guidance and assessing regulatory risks.
• Drive submission planning, regulatory compliance, and project delivery to ensure successful product development and commercialization.
• Collaborate closely with global stakeholders across Regulatory Affairs, Quality, R&D, Manufacturing, and Supply Chain functions.
• Mentor colleagues and contribute to continuous improvement initiatives, regulatory best practices, and knowledge sharing.

Skills

CMC regulatory authoring

CMC regulatory requirements

Global regulatory submissions

Regulatory strategy

Stakeholder management

Independent working

Job description

Viatris in Dublin, Ireland seeks a Regulatory Affairs Manager, CMC who will lead global CMC regulatory strategies and author high-quality submissions. You will work with R&D, Manufacturing, Quality and Regulatory teams to ensure timely approvals across global markets.

The role emphasizes independent thinking, cross-functional collaboration, and mentoring junior staff while upholding rigorous scientific standards, compliance and lifecycle management for the Upjohn product portfolio.