Global CMC Regulatory Lead for Complex Products

Viatris; Stone Cross; On-site; GBP 90,000 - 120,000; Full time

Benefits offered by this job

Excellent career progression opportuni

Work-life balance initiatives

Bonus scheme

Health insurance

Pension

Job summary

Viatris, a global healthcare company, seeks a Senior Manager, Regulatory Science CMC Complex to lead global regulatory strategies for complex pharmaceutical products across development and lifecycle. The role involves authoring and coordinating CMC submissions, identifying risks, and partnering with R&D, Quality, Regulatory Affairs and regional stakeholders to enable approvals.

You will mentor teams, drive process improvements and contribute to regulatory strategy in a fast-paced,

Qualifications

• Bachelor's degree in a scientific discipline required; Master's preferred.
• Pharmaceutical/regulatory affairs experience in CMC.
• Hands-on experience authoring CMC submissions for new registrations or post-approval variations.
• Strong knowledge of global regulatory requirements and lifecycle management.

Responsibilities

• Develop and execute global CMC regulatory strategies across development and lifecycle.
• Prepare and deliver high-quality global CMC submissions.
• Serve as the CMC regulatory lead or support Global Regulatory Leads.
• Lead responses to health authority questions and mentor teams.

Skills

Global regulatory strategy

CMC regulatory submissions

Cross-functional collaboration

Regulatory leadership

Regulatory intelligence

Project management

Education

Bachelor’s degree in a scientific discipline

Master’s degree preferred

Tools

Regulatory document management systems

Microsoft Office

Job description

Viatris, a global healthcare company, seeks a Senior Manager, Regulatory Science CMC Complex to lead global regulatory strategies for complex pharmaceutical products across development and lifecycle. The role involves authoring and coordinating CMC submissions, identifying risks, and partnering with R&D, Quality, Regulatory Affairs and regional stakeholders to enable approvals.

You will mentor teams, drive process improvements and contribute to regulatory strategy in a fast-paced,