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Disc Medicine · 14 hours ago

Senior Manager, Submission Management & Regulatory Operations

Massachusetts - Hybrid

Full-time

Hybrid

Senior Level

$137K/yr - $185K/yr

7+ years exp

Disc Medicine is a clinical-stage biopharmaceutical company focused on developing novel treatments for hematologic diseases. They are seeking a Senior Manager for Submission Management & Regulatory Operations to oversee regulatory submissions, maintain compliance, and support project teams in a dynamic hybrid work environment.

BiotechnologyHealth CareMedicalPharmaceuticalTherapeutics

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

Qualification

Regulatory OperationsVeeva RIMECTD structureDocument FormattingProject ManagementCommunication SkillsOrganizational SkillsTeam CollaborationAttention to Detail

Required

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