Global Regulatory Affairs Leader - CMC (Brands)

1100 Mylan Pharmaceuticals Inc.; Leinster; On-site; EUR 90,000 - 130,000; Full time

Benefits offered by this job

Bonus scheme

Health insurance

Pension

Career progression opportunities

Job summary

Viatris is seeking a Manager, Regulatory Affairs Brands CMC to independently prepare regulatory assessments and contribute to global regulatory strategies across the drug development and manufacturing lifecycle. You will deliver high-quality CMC submissions, manage timelines, and mentor others while collaborating with R&D, Quality, and Regulatory teams.

The role emphasizes autonomous work, regulatory risk assessment, and global conformance to CGMPs as part of advancing products from development

Qualifications

• Significant pharmaceutical regulatory experience.
• Experience with CMC authoring for registrations or variations.
• Strong written and oral communication skills.

Responsibilities

• Prepare regulatory assessments and contribute to global strategies.
• Develop robust regulatory strategies and risk mitigation.
• Prepare and deliver CMC submissions and management plans.
• Serve as CMC representative on core project teams.
• Manage regulatory issues and timelines across projects.

Skills

Regulatory writing

CMC authoring

Project management

Regulatory strategy

Communication

Microsoft Office

Documentum

Autonomous work

Education

Bachelor's degree

Master's degree (preferred)

Tools

Documentum

Microsoft Office

Job description

Viatris is seeking a Manager, Regulatory Affairs Brands CMC to independently prepare regulatory assessments and contribute to global regulatory strategies across the drug development and manufacturing lifecycle. You will deliver high-quality CMC submissions, manage timelines, and mentor others while collaborating with R&D, Quality, and Regulatory teams.

The role emphasizes autonomous work, regulatory risk assessment, and global conformance to CGMPs as part of advancing products from development