Director, Regulatory Operations

About the role

At Keros, our mission is to deliver significant clinical benefit to a wide range of patients with disorders that are linked to dysfunctional signaling of the transforming growth factor-beta (TGF-ß) family of proteins. With a focus on developing differentiated product candidates that are designed to alter TGF-β signaling, we aim to target the pathways critical for the growth, repair and maintenance of blood cells and a number of tissues, including bone, skeletal muscle, adipose and heart tissue. We believe our product candidates have the potential to unlock the full therapeutic benefits of modulating the TGF-β superfamily and provide disease-modifying benefit to patients.

Reporting to the Head Regulatory Affairs, the Director of Regulatory Operations will be responsible for establishing the Regulatory Operations role at Keros. This individual will leverage their extensive knowledge of Regulatory Operations to support Keros’ growing regulatory needs including inhouse publishing as well as working with multiple external vendors.

Responsibilities

• Oversee all Regulatory Operations deliverables, including management of Health Authority correspondence/submission archives, business administration of the Veeva Vault Regulatory Information Management system, submission management, and training of associated business processes
• Implement training strategies, develop training materials, and lead training delivery for effective adoption of Vault RIM
• Manage user groups and workflows and create and maintain archives of Health Authority interactions
• Develop, manage, and distribute reports, dashboards, and templates to meet user needs
• Contribute to the writing, review, and implementation of standards and procedures related to regulatory information management
• Partner with IT and Quality to support system validation activities
• Maintain proficiency in Vault RIM and maintain current knowledge of regulations, best practices, and guidelines related to RIM
• Provide eCTD/CTD publishing services including rendering, bookmarking, hyperlinking, compilation, table of contents creation and QC regulatory submissions to Regulatory agencies
• Coordinate publishing deliverables and act as the primary point of contact for various regulatory functions (Regulatory Affairs, CMC, Labeling, etc.) for major submissions (IND, BLA, etc.)
• Write or review internal work instructions and standard operating procedures (SOPs) pertaining to submission preparation (electronic or paper)
• Create, update and maintain submission templates that meet global regulatory requirements

Qualifications

• BA/BS or equivalent experience
• At least 12+ years of industry experience with at least 7+ years experience in regulatory operations
• Attention to detail and the ability to work individually, within a multi-disciplinary team, as well as