Global CMC Regulatory Director — Strategy & Leadership

1100 Mylan Pharmaceuticals Inc.; Dublin; On-site; EUR 140,000 - 180,000; Full time

Benefits offered by this job

Bonus scheme

Health insurance

Pension

Job summary

Viatris is seeking a Director, Regulatory Affairs CMC to lead global regulatory strategies and ensure timely submissions across markets. This senior role focuses on independent development of strategic CMC approaches to support the L-Upjohn portfolio.

You will mentor cross‑functional teams, negotiate with regulators, and drive risk management while maintaining compliance with cGMPs and quality systems.

Qualifications

• Extensive hands-on CMC authoring experience (registrations or variations).
• Experience leading matrixed & technical teams.
• Knowledge of development, commercial activities and cGMPs.
• Ability to shape project strategy and regulatory flexibility globally.
• Experience negotiating with regulatory authorities on projects.

Responsibilities

• Cultivates relationships to drive regulatory strategies and policies.
• Interprets CMC requirements and develops strategic approaches.
• Prepares and analyzes global CMC submissions and maintains compliance.
• Ensures regulatory activities meet external requirements and internal procedures.
• Leads cross-functional project teams and mentors colleagues.

Skills

CMC authoring

Regulatory leadership

Project management

Cross-functional collaboration

Stakeholder management

Job description

Viatris is seeking a Director, Regulatory Affairs CMC to lead global regulatory strategies and ensure timely submissions across markets. This senior role focuses on independent development of strategic CMC approaches to support the L-Upjohn portfolio.

You will mentor cross‑functional teams, negotiate with regulators, and drive risk management while maintaining compliance with cGMPs and quality systems.