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Director, Global Regulatory Affairs (GRA) - CMC at Ironwood Pharmaceuticals - ApplyBlast

Director, Global Regulatory Affairs (GRA) - CMC

Ironwood Pharmaceuticals

9 months ago

3.8 on Glassdoor

United States

Hybrid

Full Time

Senior

1 applicant

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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.

Skills

About Ironwood Pharmaceuticals

ironwoodpharma.com

Headquarters

Boston, Massachusetts, United States

Company Size

201-500 employees

Founded

1998

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Ironwood Pharmaceuticals is a leading gastrointestinal (GI) healthcare company on a mission to advance the treatment of GI diseases and redefine the standard of care for GI patients. The company commercializes LINZESS® (linaclotide), an approved treatment for conditions including irritable bowel syndrome with constipation and functional constipation, and maintains an active pipeline targeting additional GI indications such as Short Bowel Syndrome. With a singular focus on GI and patient-focused research, Ironwood combines scientific innovation with commercial expertise to improve outcomes for the millions of Americans affected by digestive diseases.