Regulatory Transformation Analyst — Remote

Piper Companies; Boston (MA); Remote; USD 80,000 - 90,000; Full time

Benefits offered by this job

Medical, dental, vision

401(k)

PTO

Job summary

Piper Companies seeks a Business Analyst to support a global regulatory transformation initiative within a leading pharmaceutical organization. You will partner with Regulatory Affairs, Regulatory Operations, and business stakeholders to drive process improvements, capture requirements, and assist in system-related initiatives and project delivery.

The role emphasizes workshops, BRD creation, UAT support, and change management, with a remote-friendly environment and a comprehensive benefits

Qualifications

• 6+ years of experience supporting business analysis, regulatory operations, regulatory systems, or transformation initiatives within pharmaceutical, biotech, CRO, or life sciences environments.
• Strong understanding of Regulatory Affairs, Regulatory Operations, regulatory submissions, or related pharmaceutical business processes.
• Proven experience facilitating workshops, gathering requirements, and managing stakeholder relationships.
• Experience developing process documentation, business requirements, workflows, and process maps.
• Hands-on experience supporting system implementations, technology initiatives, or software delivery projects.
• Experience supporting User Acceptance Testing (UAT), validation activities, and issue resolution.

Responsibilities

• Facilitate requirements gathering sessions and workshops with Regulatory Affairs, Regulatory Operations, and cross-functional stakeholders.
• Gather, document, validate, and manage business and functional requirements.
• Create and maintain Business Requirements Documents (BRDs), process flows, and project documentation.
• Partner with business SMEs to define and document current-state and future-state business processes.
• Support business process improvement and transformation initiatives across regulatory functions.
• Coordinate and support User Acceptance Testing (UAT), including test planning, execution support, and issue resolution.
• Act as a liaison between business stakeholders, process owners, and technical teams while supporting change management activities.

Skills

Regulatory knowledge

Business analysis

Stakeholder management

Workshops facilitation

UAT support

RIM platforms

Tools

Veeva Vault RIM

Job description

Piper Companies seeks a Business Analyst to support a global regulatory transformation initiative within a leading pharmaceutical organization. You will partner with Regulatory Affairs, Regulatory Operations, and business stakeholders to drive process improvements, capture requirements, and assist in system-related initiatives and project delivery.

The role emphasizes workshops, BRD creation, UAT support, and change management, with a remote-friendly environment and a comprehensive benefits