Global CMC Regulatory Strategy Director

Regulatory Jobs; Boston (MA); Híbrido; USD 208.000 - 244.000; Jornada completa

Descripción de la vacante

Ironwood Pharmaceuticals seeks a Director of Global Regulatory Affairs – CMC to own global CMC regulatory strategy for development, registration, and lifecycle management. You will lead regulatory input across teams, manage health authority interactions, and ensure submission readiness for multiple programs.

The role requires guiding cross-functional partners, defending regulatory positions, and driving timely approvals while maintaining inspection readiness and compliance with global

Formación

• Bachelor’s degree in a scientific discipline such as Biology, Chemistry, or Pharmaceutical Sciences; advanced degree preferred.
• Minimum of 10 years of progressively increasing responsibility in CMC Regulatory Affairs in biopharma.
• Experience leading global submissions and regulatory strategies for biologics or combination products.

Responsabilidades

• Lead global CMC regulatory strategy for development, registration and lifecycle management.
• Serve as regulatory CMC lead on internal teams and governance forums.
• Provide strategic regulatory guidance to project teams and ensure timely regulatory plans.
• Interpret global CMC requirements and ensure compliance across development and commercialization.
• Manage interactions with health authorities to align on CMC strategy and data needs.
• Prepare CMC briefing packages and regulatory narratives for meetings with regulators.
• Lead GMP inspections and inspection readiness activities.
• Coordinate global CMC submissions and lifecycle filings, including INDs and amendments.
• Collaborate with external contractors to ensure accurate regulatory deliverables.

Conocimientos

Global regulatory strategy

CMC leadership

Regulatory submissions

FDA/EMA/PMDA interactions

Regulatory affairs leadership

Inspection readiness

Cross-functional collaboration

Regulatory risk management

Project management

Educación

Bachelor's degree in science

Descripción del empleo

Ironwood Pharmaceuticals seeks a Director of Global Regulatory Affairs – CMC to own global CMC regulatory strategy for development, registration, and lifecycle management. You will lead regulatory input across teams, manage health authority interactions, and ensure submission readiness for multiple programs.

The role requires guiding cross-functional partners, defending regulatory positions, and driving timely approvals while maintaining inspection readiness and compliance with global