Global CMC Regulatory Lead for Complex Products

Viatris; Dublin; On-site; EUR 90,000 - 150,000; Full time

Benefits offered by this job

Excellent career progression

Work‑life balance

Bonus scheme

Health insurance

Pension

Job summary

McDermott Laboratories Limited, a Viatris affiliate, seeks a senior CMC regulatory professional to lead global regulatory strategies for complex products. You will coordinate submissions, work with R&D, Quality, and Regulatory Affairs, and guide teams through lifecycle projects in a fast-paced global setting.

The role emphasizes science-based decision making, risk management, and engagement with health authorities to ensure timely approvals and lifecycle success.

Qualifications

• Bachelor's degree in a scientific discipline required; Master's degree preferred.
• Significant pharmaceutical industry experience, including regulatory affairs within CMC.
• Hands-on experience authoring CMC regulatory submissions for new registrations and/or post-approval variations.
• Strong understanding of pharmaceutical development, manufacturing processes, cGMP, and lifecycle management.

Responsibilities

• Develop and execute global CMC regulatory strategies for complex products across development and lifecycle.
• Assess CMC regulatory requirements, identify risks, and develop mitigation strategies for regulatory success.
• Prepare, coordinate, and deliver high-quality global CMC regulatory submissions (registrations, changes, renewals).
• Support Global Regulatory Leads or act as the Global Regulatory Lead for products/projects.
• Serve as CMC regulatory SME on cross-functional teams with R&D, Quality, Regulatory Affairs and regional stakeholders.
• Manage regulatory commitments, submission timelines, agency interactions, and regulatory intelligence.

Skills

Communication skills

Project management

Regulatory knowledge

Problem solving

Scientific judgment

MS Office

Regulatory submissions

Education

Bachelor's degree in science

Master's degree preferred

Tools

Regulatory document management systems

MS Office

Job description

McDermott Laboratories Limited, a Viatris affiliate, seeks a senior CMC regulatory professional to lead global regulatory strategies for complex products. You will coordinate submissions, work with R&D, Quality, and Regulatory Affairs, and guide teams through lifecycle projects in a fast-paced global setting.

The role emphasizes science-based decision making, risk management, and engagement with health authorities to ensure timely approvals and lifecycle success.