Senior Manager/Associate Director, Regulatory Operations

In this role, the Senior Manager/ Associate Director of Regulatory Operations will be responsible for providing support for all Health Authority submission-related activities including: high quality compilation of submission-ready documents, creating a quality submission output, and the transmission of submissions to the Health Authority. This individual will ensure that all electronic regulatory submissions performed on behalf of Keros Therapeutics are compliant with Health Authority regulations and Keros document standards. In addition, this individual will contribute to supporting the Keros Regulatory infostructure, including offering Veeva Vault Regulatory Information Management (RIM) and submission management support.

Responsibilities

• Support Regulatory Operations deliverables, including management of Health Authority correspondence/submission archives, business administration of the Veeva Vault RIM system, submission management, and training of associated business processes.

• Prepare submission sequences and the maintenance of all US submissions including but not limited to Initial INDs, Meeting Request/Meeting packages, IND Amendments, Orphan Drug applications, Annual Reports, Safety Reports, Development Safety Update Reports (DSUR), and future regions as deemed by Company goals.

• Provide eCTD/CTD publishing services including: rendering, bookmarking, hyperlinking, compilation, table of contents creation, and the QC of regulatory submissions to Regulatory agencies.

• Coordinate publishing deliverables and act as the primary point of contact for various regulatory functions (Regulatory Affairs, CMC, etc.) for major submissions (IND, BLA, etc.).

• Maintain proficiency in Veeva Vault RIM and maintain current knowledge of regulations, best practices, and guidelines related to RIM.

• Manage user groups and workflows and create and maintain archives of Health Authority interactions.

• Develop, manage, and distribute reports and dashboards. Troubleshoot template issues and train users upon the use of templates.

• Contribute to the writing, review, and implementation of standards and procedures related to regulatory information management.

• Assist in writing and/or reviewing internal work instructions and standard operating procedures (SOPs) pertaining to submission preparation.

• Assist regulatory leads with the submission management of their programs.

Qualifications

Basic Qualifications

• Bachelor's degree in a scientific discipline or systems technology or equivalent experience.

• 10 years (or, more) experience within Regulatory Operations as a publisher.

• Must be able to publish both in Word and in Adobe Acrobat.

• Must be able to publish documents from all five FDA modules.

• Must be able to publish both granular and concatenated IMPDs in both Word and Adobe Acrobat.

• An emphasis is placed upon the ability to publish granular Word CSRs with the end result being a compliant CSR PDF.

• Be willing to train others in the use of our eCTD Viewer, EndNote, Veeva RIM and other relevant systems.

• 5 years of experience as a Veeva Vault RIM business administrator.

• Be willing to train others in the use of a configured version of the Veeva Vault RIM Essentials package.

• Assist with configuration changes and the required Quality processes (change control, validation review, document revisions, SOP updates etc.).

• Be willing to be a day-to-day user of the Veeva Vault RIM system as well as assisting in troubleshooting end user issues.

Preferred Qualifications

• Platform administrator certification in Veeva

• Experience using ISIToolbox (now DXC Toolbox)

• Advanced Word and Adobe Acrobat skills

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