Job SummaryThe RIM Business Analyst & Managed Services Consultant is responsible for:
- Serving as the primary liaison between Regulatory Affairs/Operations business stakeholders and IT/platform teams, translating regulatory business needs into system requirements and configuration specifications.
- Supporting implementation, migration, and ongoing managed services engagements across Regulatory Information Management (RIM) platforms, independent of underlying vendor (e.g., Veeva Vault RIM, Generis CARA, Ennov RIM, ArisGlobal LOOP, MasterControl RIM, EXTEDO RIMS).
- Facilitating requirements gathering, process mapping, and vendor-neutral system evaluation to support client regulatory technology strategy and roadmap decisions.
- Acting as the functional point of contact for client-reported issues, enhancement requests, and release management activities, coordinating with technical configuration and IT teams to deliver resolution.
Essential Functions:- Business Analysis & Requirements
- Facilitate requirements-gathering workshops with Regulatory Affairs/Operations stakeholders to capture business needs, pain points, and process gaps.
- Translate business requirements into functional specifications, user stories, and configuration/change requests for IT and system configuration teams.
- Conduct as-is/to-be process mapping for regulatory submission, registration, and publishing workflows.
- Perform vendor-neutral system evaluations and gap assessments across RIM platforms (Veeva Vault RIM, Generis CARA, Ennov RIM, ArisGlobal LOOP, MasterControl RIM, EXTEDO RIMS) to support platform selection and roadmap decisions.
Cross-Functional Liaison (Regulatory & IT)- Serve as the primary liaison between Regulatory Affairs/Operations business owners and internal or client IT, data, and platform engineering teams.
- Own the requirements traceability matrix and ensure configuration changes reflect approved business requirements.
- Coordinate with platform administrators (Veeva Vault Admin, Salesforce Admin, or equivalent) to implement approved configuration changes across document types, lifecycles, workflows, security models, and integrations.
- Define integration requirements between RIM systems and adjacent enterprise platforms (Salesforce CRM/Health Cloud, SAP, ServiceNow, Quality and Safety systems) where regulatory data flows across the broader enterprise landscape.
Managed Services & Continuous Improvement- Own intake, triage, and prioritization of managed services requests and tickets across client RIM environments, regardless of platform.
- Support release management processes, including regression testing coordination, UAT script development and execution, and release notes review, for whichever RIM or adjacent platform a client operates.
- Identify and document process improvement and automation opportunities across the regulatory technology landscape.
- Maintain SOPs, business process documentation, and system configuration specifications for client-facing and internal use.
Submission & Registration Domain Knowledge- Apply working knowledge of eCTD structure (ICH M8) and regional submission requirements (FDA, EMA, Health Canada) to inform requirements and configuration recommendations, independent of the publishing or RIM platform in use.
- Support Submission Content Plan design, registration/license data modeling, and health authority correspondence tracking requirements across RIM platforms.
Training & Enablement- Develop and deliver end-user training, quick reference guides, and change management materials tied to new system functionality or process changes.
Necessary Skills and Abilities: - Demonstrated business analysis skills: requirements elicitation, process mapping, functional specification writing, and backlog/user story authoring.
- Working knowledge of at least one enterprise RIM platform (Veeva Vault RIM, Generis CARA, Ennov RIM, ArisGlobal LOOP, MasterControl RIM, or EXTEDO RIMS), with the ability to learn others quickly.
- Familiarity with the broader regulatory technology and enterprise systems landscape, including Salesforce (CRM/Health Cloud), ServiceNow, SAP, or comparable platforms, and how regulatory data intersects with them.
- Understanding of eCTD structure (ICH M8), regional submission requirements, and RIM/registration data models, independent of vendor.
- Understanding of GxP computer system validation (CSV) principles as applied to configuration changes in a regulated environment.
- Strong facilitation and stakeholder management skills; comfortable running workshops with both business and technical audiences.
- Ability to translate ambiguous business needs into clear, testable requirements and configuration specifications.
- Excellent written and verbal communication skills; capable of presenting to both regulatory business stakeholders and IT/engineering teams.
- Ability to manage multiple client environments, platforms, and competing priorities in a consulting/services setting.
Educational Requirements:- Bachelor's degree in Life Sciences, Information Systems, Business Administration, or a related field.
Experience Requirements: - 3-5+ years of business analyst experience within regulatory affairs/regulatory operations technology environments, spanning at least one RIM platform (Veeva Vault RIM, Generis CARA, Ennov RIM, ArisGlobal LOOP, MasterControl RIM, EXTEDO RIMS, or equivalent).
- Business analysis certification (e.g., CBAP, CCBA) or a relevant platform certification (Veeva, Salesforce, or equivalent) a plus, but not required given the platform-agnostic scope of this role.
- Demonstrated experience supporting at least one full RIM implementation, migration, or major upgrade lifecycle in a business analyst or requirements-owner capacity.
- Experience working across multi-system enterprise landscapes (e.g., RIM plus Salesforce, ServiceNow, SAP, or Quality/Safety systems) preferred.
- Prior consulting, systems integrator, or managed services experience supporting life sciences clients preferred., and exceptional client outcomes
This job description may not be inclusive of all assigned duties, responsibilities, or aspects of the job described, and may be amended at any time at the sole discretion of the Employer.
