IT Business Analyst, Regulatory

Rhythm Pharmaceuticals • Boston, MA

7d • $90,000 - $135,000 • Hybrid

About The Position

Reporting to the Director, IT Business Partner, R&D, this role will serve as the primary IT Business Analyst for Regulatory Affairs. The analyst will translate Regulatory business needs into scalable technology, data, and process solutions. The role will support the lifecycle of Regulatory applications and initiatives, including discovery, requirements, process design, implementation, validation, adoption, operational support, and continuous improvement in a global biopharmaceutical environment. This role combines business partnership with hands-on business analysis, solution delivery, and application support, working closely with Regulatory stakeholders, Quality, IT colleagues, and external vendors.

Requirements

• 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.

Nice To Haves

• Experience with Veeva Quality or comparable QMS, validated SaaS platforms, Microsoft 365, SharePoint, Smartsheet, reporting tools, APIs, and secure file-transfer patterns.
• Experience with submission lifecycle, publishing, IDMP or structured data concepts, labeling, regulatory intelligence, or regulatory CMC.
• Experience managing SaaS vendors, implementation partners, support SLAs, releases, and enhancement backlogs.
• CBAP, PMI-PBA, CSPO, PMP, Agile, Veeva, or relevant life-sciences technology certification.
• Experience with Veeva Vault RIM suite or comparable RIM platforms; experience with Registrations, Submissions, Submissions Archive, or Publishing.
• Experience with electronic document and content management, structured content, submission publishing, regulatory intelligence, and health authority gateway solutions.
• Experience with health authority interactions, requests for information, response tracking, and inspection-ready evidence.
• Experience with one or more related areas such as Regulatory CMC, labeling, medical writing, document management, regulatory intelligence, and cross-functional dossier collaboration.
• Experience with regulatory data governance, metadata, taxonomy, reporting, reconciliation, and integration between regulatory, quality, clinical, safety, and document platforms.
• Experience supporting system integrations, data migration, role-based security, audit trails, dashboards, and vendor-hosted platforms.
• Relevant business analysis, product ownership, project management, Agile, Veeva, or life-sciences technology certification.

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.

Benefits

• A discretionary annual bonus may be available based on individual and company performance.
• This role may be eligible for benefits and other compensation such as restricted stock units.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level