Global Branded CMC Strategy Lead

1100 Mylan Pharmaceuticals Inc.; Dublin; On-site; EUR 120,000 - 180,000; Full time

Job summary

Viatris seeks a Senior Manager Global Branded CMC Strategy to independently prepare regulatory assessments and contribute to global strategies across the drug development and manufacturing lifecycle. You will lead CMC activities, manage submission planning, and collaborate with Regulatory, Quality, R&D and regional teams worldwide.

The role demands advanced CMC expertise, strong communication, and the ability to mentor colleagues while supporting continuous improvement and policy implementation

Qualifications

• Hands-on CMC authoring experience (initial registrations or post-approval variations).
• Knowledge of development and commercial activities and cGMPs to assess technical, scientific and regulatory merits.
• Advanced knowledge of regulatory CMC/policy/publishing disciplines.

Responsibilities

• Ensure global regulatory compliance across markets and internal procedures.
• Develop and implement global regulatory CMC strategies.
• Prepare, review, and deliver CMC submissions for registrations and post-approval changes.

Skills

CMC authoring

Regulatory strategy

Regulatory compliance

Cross-functional collaboration

Documentation systems

Project management

Submissions management

Microsoft Office

Tools

Documentum

Microsoft Office Suite

Job description

Viatris seeks a Senior Manager Global Branded CMC Strategy to independently prepare regulatory assessments and contribute to global strategies across the drug development and manufacturing lifecycle. You will lead CMC activities, manage submission planning, and collaborate with Regulatory, Quality, R&D and regional teams worldwide.

The role demands advanced CMC expertise, strong communication, and the ability to mentor colleagues while supporting continuous improvement and policy implementation