Director, Regulatory Operations

Keros Therapeutics•Lexington, MA

About The Position

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.

Requirements

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 with external partners and vendors
Prior experience running large scale RA projects within the biotech industry
Extensive knowledge of eCTD, e-publishing systems for preparing regulatory submissions as well as regulatory management systems (e.g. Veeva RIM)
Experienced in MS Word, Excel, PowerPoint, and Adobe Acrobat, Veeva Vault RIMs
Ability to thrive in a collaborative and fast-paced team environment

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