Director, Global Regulatory Affairs (GRA) - CMC

Ironwood Pharmaceuticals(5 days ago)

HybridFull TimeSenior$208,000 - $243,600Regulatory Affairs

About this role

Ironwood Pharmaceuticals is seeking a Director of Global Regulatory Affairs – CMC to lead their global chemical, manufacturing, and controls (CMC) regulatory strategy for their biopharmaceutical products. The role involves ensuring compliance with global regulations, managing interactions with health authorities, and leading regulatory submissions to facilitate clinical development and commercialization.

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Required Skills

Regulatory Strategy
CMC
Global Submissions
Health Authorities
GMP Inspections
Regulatory Compliance
Drug-Device Combination
Lifecycle Management
Biologics
Project Management

About Ironwood Pharmaceuticals

ironwoodpharma.com

Ironwood Pharmaceuticals is a biopharmaceutical company focused on discovering, developing, and commercializing therapies for gastrointestinal (GI) diseases. The company discovered and developed linaclotide (LINZESS), an approved treatment for irritable bowel syndrome with constipation (IBS‑C) and chronic idiopathic constipation, and advances additional programs targeting digestion, motility and visceral pain. Ironwood combines in‑house research and clinical development with commercial partnerships to bring treatments to patients and is headquartered in the Boston, Massachusetts area. The company emphasizes patient‑focused research, scientific innovation, and long‑term commitment to improving digestive health.

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