Global Regulatory Affairs & Process Excellence Lead

1100 Mylan Pharmaceuticals Inc.; Dublin; Hybrid; EUR 90,000 - 130,000; 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 Senior Manager, Global Regulatory Affairs – Business Process to lead design, development and optimization of regulatory processes. You will work with cross-functional teams to ensure consistency, training, and adherence across regulatory programs.

The role emphasizes process governance, data-driven improvements, and collaboration with Compliance, L&D and Metrics teams to drive continuous improvement in regulatory operations.

Qualifications

• Experience in Regulatory Affairs function within Pharmaceutical, Biotech, or other highly regulated industries required.
• Previous experience in process design and project management preferred.
• Compliance background preferred.
• Comprehensive knowledge of departmental and organizational policies, procedures and systems.
• Six Sigma or other project management certification preferred.
• Basic flowcharting skills (Visio) preferred.

Responsibilities

• Process Optimization and Design: Lead design, development, implementation and optimization of regulatory processes; coordinate cross-functional teams and align on regulatory systems.
• Regulatory Process Adherence Oversight: Develop and monitor adherence, train on new processes, and support CAPA with cross-functional alignment.
• Analytics & continuous improvement: Use data to identify trends and opportunities for regulatory process improvements.

Skills

Regulatory Affairs

Process design

Project management

Six Sigma

Visio

Job description

Viatris is seeking a Senior Manager, Global Regulatory Affairs – Business Process to lead design, development and optimization of regulatory processes. You will work with cross-functional teams to ensure consistency, training, and adherence across regulatory programs.

The role emphasizes process governance, data-driven improvements, and collaboration with Compliance, L&D and Metrics teams to drive continuous improvement in regulatory operations.