Regulatory IT Business Analyst - RIM & Submissions

Rhythm Pharmaceuticals Inc.; Boston (MA); Hybrid; USD 90,000 - 135,000; Full time

Benefits offered by this job

Hybrid work model

Discretionary bonus

Competitive pay

Job summary

Rhythm Pharmaceuticals Inc. is seeking an IT Business Analyst for Regulatory Affairs to translate business needs into scalable technology and data solutions. The role supports global regulatory applications lifecycle, delivers process improvements, and collaborates with Quality, IT, and external vendors in a hybrid model.

The candidate will work closely with Regulatory stakeholders to optimize information management, submissions, and compliance while ensuring readiness for inspections.

Qualifications

• Bachelor's degree in information systems, computer science, life sciences, or a related field, or equivalent practical experience.
• 5+ years of progressively responsible business analysis, product ownership, application management, or technology delivery experience in a life-sciences or biopharmaceutical environment.
• Experience supporting Regulatory Affairs processes and applications in pharmaceutical, biotechnology, medical device, or another regulated life-sciences environment.
• Working knowledge of regulatory submission planning, content coordination, publishing handoffs, filing, tracking, archival, and post-submission lifecycle activities.
• Experience with regulatory information management processes involving products, registrations, applications, commitments, correspondence, labeling and controlled vocabularies.
• Strong elicitation, process mapping, requirements, testing, documentation, analytical, facilitation, and stakeholder-management skills.
• Demonstrated ability to manage competing priorities, work independently within established direction, influence outcomes, and contribute hands-on when needed.
• Excellent written and verbal communication skills with a strong customer-service, technology advisory, and partnership mindset.
• Hands-on Veeva Vault RIM implementation, expansion, migration, or operational support experience.
• Knowledge of GxP computerized system validation, 21 CFR Part 11, electronic records controls, audit readiness, and data integrity principles.
• Experience supporting validated applications, including testing, role-based security, audit trails, change control, or other regulated-system controls.

Responsibilities

• Build strong partnerships with Regulatory Affairs, Regulatory Operations, Regulatory CMC, Labeling, Medical Writing, Quality, and other R&D stakeholders to understand goals, pain points, risks, and priorities and serve as a technology subject-matter resource for assigned systems and processes.
• Conduct discovery through interviews, workshops, document analysis, process observation, and data review; translate findings into business and functional requirements, user stories, acceptance criteria, and process flows.
• Map current-state and future-state regulatory processes, identify control gaps and inefficiencies, and support the development of practical, scalable improvements in partnership with business process owners.
• Partner with stakeholders and the Director, IT Business Parter R&D, to assess business demand, enhancements, and project opportunities and provide input into prioritization based on business value, risk, urgency, and available resources.
• Support the technology and information-management needs associated with global regulatory planning, registration strategies, health authority interactions, and post-approval commitments.
• Support Regulatory Information Management capabilities, including registration data, submission planning and tracking, health authority correspondence, commitments, Labeling management, product and dossier information, publishing handoffs, and regulatory intelligence use cases.
• Partner with business and technical teams to expand adoption and harmonize processes for Veeva RIM or comparable regulatory platforms.
• Support integrations, data migration, master data, reporting, dashboards, periodic submission tracking, notifications, and controlled document exchanges across regulatory and enterprise platforms.
• Coordinate requirements traceability, test strategy, test scripts, user acceptance testing, defect triage, release readiness, training, and user documentation for assigned initiatives.
• Coordinate application support, issue resolution, root-cause analysis, enhancement intake, release planning, and vendor performance for assigned systems.
• Ensure projects and changes follow applicable IT lifecycle, change control, validation, security, privacy, data integrity, records management, and GxP procedures.
• Partner with Regulatory Affairs, Quality, and IT stakeholders to maintain assigned regulatory systems, processes, and records in an inspection-ready state
• Develop business cases, scope documents, decision papers, roadmap inputs, RAID logs, governance materials, operating procedures, and support documentation.
• Communicate dependencies, status, decisions, and risks to cross-functional teams and senior leadership.
• Contribute to the R&D technology roadmap and support the evaluation of automation, analytics, workflow, and responsible AI opportunities for Regulatory Affairs.

Skills

IT Business Analysis

Regulatory Affairs

Stakeholder Management

Requirements Gathering

Process Improvement

Communication

Education

Bachelor's degree in information systems, computer science, life sciences, or related field

Tools

Veeva Vault RIM

RIM Systems

Microsoft 365 / SharePoint

Job description

Rhythm Pharmaceuticals Inc. is seeking an IT Business Analyst for Regulatory Affairs to translate business needs into scalable technology and data solutions. The role supports global regulatory applications lifecycle, delivers process improvements, and collaborates with Quality, IT, and external vendors in a hybrid model.

The candidate will work closely with Regulatory stakeholders to optimize information management, submissions, and compliance while ensuring readiness for inspections.