Director, Regulatory Operations

Keros Therapeutics

Director of Regulatory Operations at a clinical-stage biotech company focused on TGF-β modulation. Establish and lead regulatory operations function, managing submission archives, implementing Veeva Vault RIM systems, overseeing eCTD publishing, and coordinating with cross-functional teams on regulatory submissions.

Responsibilities

Oversee regulatory operations deliverables including submission archives and RIM system administration
Develop and deliver training strategies for Veeva Vault RIM adoption across organization
Manage eCTD/CTD publishing services including rendering, bookmarking, and submission QC
Coordinate submission deliverables with regulatory affairs, CMC, and labeling functions
Create and maintain submission templates, SOPs, and regulatory information management procedures

Requirements

Bachelor's degree in relevant field or equivalent experience
12+ years industry experience with 7+ years in regulatory operations
Extensive eCTD and e-publishing systems knowledge for regulatory submissions
Proficiency with Veeva Vault RIM and related regulatory management systems
Demonstrated experience managing large-scale regulatory affairs projects in biotech
Skilled in Word, Excel, PowerPoint, Adobe Acrobat, and submission management tools

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Vacancy posted 7 days ago

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