Global CMC Regulatory Lead for Complex Products

1100 Mylan Pharmaceuticals Inc.; Dublin; On-site; EUR 110,000 - 140,000; Full time

Benefits offered by this job

Career progression

Work-life balance

Bonus scheme

Health insurance

Pension

Job summary

Viatris is seeking a Senior Manager, Regulatory Science CMC Complex in Ireland to lead global CMC regulatory strategies for complex pharmaceutical products across development and lifecycle management. You will prepare high-quality submissions and manage regulatory interactions with health authorities while guiding cross-functional teams.

The role requires strong expertise in CMC regulatory affairs, NDA/ANDA-like processes, and collaboration with R&D, Quality and regulatory stakeholders to secure

Qualifications

• Bachelor's degree in a scientific discipline is required.
• Master's degree is preferred for advanced responsibilities.
• Hands-on experience with CMC regulatory submissions is essential.
• Strong knowledge of global regulatory requirements and lifecycle management.

Responsibilities

• Develop and execute global CMC regulatory strategies for complex products.
• Prepare and deliver high-quality CMC submissions (registrations, variations, renewals).
• Lead regulatory responses and mentor teammates on complex submissions.
• Collaborate with R&D, Quality, Regulatory Affairs and regional teams to drive regulatory success.

Skills

CMC regulatory

Regulatory affairs

Lifecycle management

Cross-functional collaboration

Project management

Written communication

Regulatory strategy

Microsoft Office

Education

Bachelor's degree in a scientific discipline

Master's degree preferred

Tools

Regulatory document management systems

Microsoft Office

Job description

Viatris is seeking a Senior Manager, Regulatory Science CMC Complex in Ireland to lead global CMC regulatory strategies for complex pharmaceutical products across development and lifecycle management. You will prepare high-quality submissions and manage regulatory interactions with health authorities while guiding cross-functional teams.

The role requires strong expertise in CMC regulatory affairs, NDA/ANDA-like processes, and collaboration with R&D, Quality and regulatory stakeholders to secure