Director, CMC Sciences Project Management

Role overview

This is a director-level opportunity in Dublin for a major global pharmaceutical organization undergoing a wide-ranging transformation. The program is focused on reducing cost and modernizing the supply chain across a global network of 145+ markets. The work covers drug product site transfers, sourcing changes for active pharmaceutical ingredients and drug substances, and lifecycle variations after approval.

The role sits within a newly established leadership workstream and is intended to drive delivery of a defined portion of the broader program. You will have direct oversight of a substantial external contractor team that carries out the operational execution. This is a true program leadership position rather than a PMO-only assignment, so a strong CMC regulatory foundation and the ability to lead cross-functionally at speed are essential.

Key responsibilities

• Take full ownership of a defined segment of a major global CMC program, guiding it from strategic planning through execution.
• Shape the CMC approach for post-approval and lifecycle changes, including preparation of Module 3 documentation and Module 2 Quality Overall Summaries.
• Create and maintain trackers, dashboards, and performance metrics that clearly show workload versus available resources.
• Lead and monitor a team of external contractors responsible for delivering the operational workstream.
• Serve as the CMC point of contact across functions such as R&D, Quality, and Operations, while protecting scope and standing behind regulatory requirements.
• Support a broad product range that includes branded products, generics, complex generics, and value-added products.
• Work with both major and emerging markets, including situations where local regulatory guidance may be limited or evolving.

Requirements

• Demonstrated experience in CMC regulatory affairs, with direct hands-on authorship of Module 3 and Module 2 QOS documents.
• Proven ability to build CMC strategy for post-approval changes and lifecycle variations.
• Strong program and project management background, including tracker management, dashboard reporting, and coordination across multiple stakeholders.
• Clear, confident communication style with the credibility to challenge and influence cross-functional partners.
• Ability to operate effectively in a fast-paced, high-pressure, and uncertain environment.
• Exposure to generics, complex generics, or global multi-region markets would be beneficial.
• Candidates must already have the legal right to work in Ireland, as sponsorship is not available.

Work location

The position is based in Dublin, Ireland, with a hybrid schedule requiring three days per week on site.

Additional information

No sponsorship is available for this opportunity. Applicants must already be eligible to work in Ireland.