Senior Manager, Submission Management & Regulatory Operations

POSITION OVERVIEW:

Disc Medicine is seeking a detail-oriented and experienced Regulatory Operations senior submission manager, reporting to the Head of Regulatory Operations. This full-time role will be instrumental in tracking and managing investigational and marketing submissions from planning to post-dispatch activities, formatting regulatory documents as needed, maintaining Veeva RIM inputs, representing Regulatory Operations in project team meetings, interacting with project team members and Regulatory vendors, authoring best practices and providing associated training as assigned, and other Regulatory Operations projects as needed.

RESPONSIBILITIES:

• Manage the coordination and publishing of submissions to regulatory Health Authorities in the appropriate format using Veeva RIM
• Monitor submission timelines and proactively identify risks or delays, leveraging Veeva RIM dashboards and reporting tools for visibility and tracking
• Maintain accurate, audit-ready records and metadata within Veeva RIM to support regulatory compliance and inspection readiness
• Provide support to Regulatory Staff by processing submission objects and content plans within Veeva RIM, ensuring proper document formatting, and incorporating bookmarks and hyperlinks as required
• Archive regulatory submissions and correspondences; process submission metrics and reports as necessary
• Maintain regulatory tracking tools as needed
• Maintain current knowledge of existing and emerging regulations, standards, or guidance’s related to electronic submission and publishing requirements
• Coordinate with external partners for operational deliverables including support of publishing and/or Veeva RIM on and off boarding
• Manage and resolve publishing-related issues encountered during validation as needed
• Maintain regulatory submission tracking reports
• Provide support in the development of standard operational procedures, work instructions, and systems to ensure regulatory compliance
• Maintain clinical trial regulatory compliance tracking for ongoing development programs
• Provide training and guidance to project team members on Veeva RIM functionality and best practices
• Support the organization in maintaining a work environment focused on quality and that fosters learning, open communication, and teamwork
• Assist in the development and refinement of submission templates and SOPs.
• Other duties as assigned

 REQUIREMENTS:

• Bachelor’s degree in Pharmaceutical, Biological or related field.
• Minimum of 7+ years’ overall experience in the biopharmaceutical/biotech industry and 5+ years of direct experience with Regulatory Operations activities and regulatory submissions. NDA/MAA application experience is a plus.
• Demonstrated knowledge of best practices and proficient use of applications in managing submissions and preparing submission content, i.e., Veeva RIM, MS Word, Excel, SharePoint, SmartSheet, Adobe Acrobat with Toolbox Pharma plug-in, and Starting Point templates.
• Demonstrates strong project management skills and attention to detail.
• Proficient hands-on working experience with Veeva RIM Submissions and Submissions Archive applications is required. Other RIM suite applications a plus.
• Strong knowledge of eCTD structure, FDA/EMA submission requirements, document formatting standards, and eCTD QC activities.
• Ability to interpret and implement regulatory legislation and/or updates.
• Proven ability to effectively multi-task and work under tight deadlines; must possess excellent organizational skills.
• Excellent communication and interpersonal skills; must be self-motivated with eagerness to grow professionally and learn.
• Ability to work independently and manage multiple priorities in a fast-paced environment.
• Personal attributes include: flexibility and integrity, good judgment and decision-making skills, action- and results-oriented, collaborative and team-oriented
• Occasional travel required, as needed.