Global CMC Regulatory Lead for Complex Products

Viatris; Dublin; On-site; EUR 120,000 - 150,000; Full time

Benefits offered by this job

Health insurance

Pension

Bonus scheme

Career progression

Work-life balance

Job summary

Viatris seeks a Senior Manager, Regulatory Science CMC Complex to develop and execute global CMC regulatory strategies for complex products across development and lifecycle management. You will lead high-quality submissions and collaborate with R&D, Quality, and Regulatory Affairs.

The role requires strong regulatory experience, excellent communication, and the ability to drive parallel projects in a global environment. A Master’s degree is preferred with solid industry knowledge.

Qualifications

• Bachelor’s degree in a scientific discipline required; Master’s degree preferred.

Responsibilities

• Develop and execute global CMC regulatory strategies for complex pharmaceutical products across development and lifecycle management.
• Independently assess CMC regulatory requirements, identify risks, and develop mitigation strategies.
• Prepare, coordinate, and deliver high-quality global CMC regulatory submissions (new registrations, post-approval changes, renewals, annual reports, line extensions).
• Support Global Regulatory Leads or act as Global Regulatory Lead for assigned products and major regulatory projects.
• Serve as the CMC regulatory representative on cross-functional project teams with R&D, Quality, Regulatory Affairs, Technical Operations, and regional stakeholders.
• Manage regulatory commitments, submission timelines, agency interactions, and regulatory intelligence activities with minimal supervision.
• Lead responses to health authority questions and provide quality review of complex regulatory submissions.
• Act as a scientific/technical subject matter expert, mentoring colleagues and project teams.
• Contribute to regulatory process improvements and high-priority business projects.
• Build and maintain relationships with regulatory authorities and internal stakeholders.

Skills

Regulatory strategy

CMC experience

Global submissions

Cross-functional leadership

Risk management

Project management

Written communication

Regulatory intelligence

cGMP knowledge

Pharma industry

Education

Bachelor's degree in science

Master's degree preferred

Tools

Regulatory document management systems

Microsoft Office

Job description

Viatris seeks a Senior Manager, Regulatory Science CMC Complex to develop and execute global CMC regulatory strategies for complex products across development and lifecycle management. You will lead high-quality submissions and collaborate with R&D, Quality, and Regulatory Affairs.

The role requires strong regulatory experience, excellent communication, and the ability to drive parallel projects in a global environment. A Master’s degree is preferred with solid industry knowledge.