Regulatory IT Business Analyst - R&D Compliance

Rhythm Pharmaceuticals Inc.

Boston (MA)

Hybrid

USD 90,000 - 135,000

Full time

4 days ago
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Benefits offered by this job

Hybrid work model
Travel flexibility
Discretionary bonus
RSU eligibility

Job summary

Rhythm Pharmaceuticals Inc. is seeking a Regulatory IT Business Analyst to translate regulatory needs into scalable tech and processes.

You will partner with Regulatory Affairs, Quality, and IT teams to support global regulatory planning, data management, and submission lifecycle, including system support and continuous improvement. This Boston-based, hybrid role requires experience in regulatory information management, Veeva Vault RIM, and strong stakeholder management.

Qualifications

  • Bachelor’s degree or equivalent practical experience in information systems, life sciences, or related field.
  • 5+ years of progressively responsible business analysis, product ownership, application management, or technology delivery in life sciences or biopharma.
  • Experience supporting Regulatory Affairs processes and applications in regulated life sciences.
  • Knowledge of regulatory submission planning, content coordination, publishing, and filing lifecycle.
  • Experience with regulatory information management involving products, registrations, and labeling.

Responsibilities

  • Build partnerships with Regulatory Affairs, Regulatory Operations, Labeling, Quality, and other R&D stakeholders to understand goals and priorities.
  • Translate discovery findings into business requirements, user stories, and process flows.
  • Map current and future regulatory processes and identify inefficiencies for scalable improvements.
  • Assess business demand and help prioritize projects based on value, risk, and resources.
  • Support global regulatory planning, registration strategies, and post-approval commitments.
  • Coordinate requirements traceability, testing, and user acceptance testing for initiatives.
  • Manage vendor performance, issue resolution, and release planning for assigned systems.

Skills

Stakeholder management
Regulatory information management
Requirements gathering
Process mapping
Business analysis
Veeva Vault RIM

Education

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

Tools

Veeva Vault RIM

Job description

Rhythm Pharmaceuticals Inc. is seeking a Regulatory IT Business Analyst to translate regulatory needs into scalable tech and processes.

You will partner with Regulatory Affairs, Quality, and IT teams to support global regulatory planning, data management, and submission lifecycle, including system support and continuous improvement. This Boston-based, hybrid role requires experience in regulatory information management, Veeva Vault RIM, and strong stakeholder management.

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