Global CMC Regulatory Affairs Director

Viatris; Dublin; On-site; EUR 150,000 - 190,000; Full time

Benefits offered by this job

Health insurance

Pension

Bonus scheme

Work-life balance initiatives

Excellent career progression

Job summary

Viatris is seeking a Director, Regulatory Affairs CMC to lead global CMC regulatory strategies for the L-Upjohn portfolio. The role focuses on developing strategic approaches and coordinating complex submissions across multiple markets.

The incumbent will manage a matrixed team, partner with Regulatory, Manufacturing, Quality, and Commercial functions, and represent Viatris in industry forums to advance regulatory objectives and ensure product compliance.

Qualifications

• Extensive hands-on CMC authoring experience (initial registrations or post-approval variations).
• Experience leading matrixed & technical teams.
• Knowledge of development & commercial activities and cGMPs to assess CMC information and data.
• Understanding of regulatory requirements globally and ability to negotiate with authorities.

Responsibilities

• Develop strategic CMC regulatory approaches to expedite submissions for the L-Upjohn portfolio.
• Cultivate relationships with stakeholders to align regulatory strategies.
• Prepare and analyze global CMC submission documentation and manage CMC change control.
• Ensure compliance with external regulatory requirements and internal procedures.
• Lead governance and contribute to cross-functional projects and initiatives.

Skills

CMC authoring

Regulatory strategy

Project management

Regulatory submissions

Communication with regulators

Education

Advanced degree in life sciences

Job description

Viatris is seeking a Director, Regulatory Affairs CMC to lead global CMC regulatory strategies for the L-Upjohn portfolio. The role focuses on developing strategic approaches and coordinating complex submissions across multiple markets.

The incumbent will manage a matrixed team, partner with Regulatory, Manufacturing, Quality, and Commercial functions, and represent Viatris in industry forums to advance regulatory objectives and ensure product compliance.