Amtex Systems Inc
Lead - "Global Talent Acquisition" at Amtex Systems Inc
Foster City, CA - hybrid
Look for candidates from West coast only
Pharma/ Biotech/ Life Sciences/ Medical Device/ Healthcare or Manufacturing experience is a must
Look for Veeva Business Analyst with Registration and Documentation experience.
8-10 Year candidate required
Person should understand how data is set up in registration module and how it will interact with SAP systems.
Our company is seeking an experienced Business Analyst with expertise in Veeva RIM Registrations and Integrations with SAP to join our team.
The successful candidate will be responsible for analyzing business requirements, designing solutions, and implementing changes to streamline our Veeva RIM Registration process and SAP integrations.
Responsibilities
Analyze business requirements related to Veeva RIM Registrations and SAP integrations, and identify gaps in existing processes
Design solutions and provide recommendations for process improvements related to Veeva RIM Registrations and SAP integrations
Implement changes to streamline the Veeva RIM Registration process and SAP integrations
Collaborate with cross-functional teams to develop and implement Veeva RIM Registration and SAP integration projects
Provide support and guidance to end‑users in the Veeva RIM Registration process and SAP integrations
Identify and mitigate risks related to Veeva RIM Registration and SAP integration projects
Document business processes, requirements, and system configurations related to Veeva RIM Registrations and SAP integrations
Requirements
Bachelor’s degree in business administration, Information Technology, or related field
3+ years of experience as a Business Analyst, with a focus on Veeva RIM Registrations and Integrations with SAP
Strong understanding of the Veeva RIM Registration process and experience working with Veeva Vault RIM
Role Overview The Business Analyst will support Regulatory Information Management (RIM) processes with a primary focus on Active Dossiers and the Submission Management module. The role is responsible for gathering requirements, analyzing end-to-end regulatory workflows, supporting submission lifecycle tracking, and helping ensure accurate, audit-ready data within the RIM platform. This position partners closely with Regulatory Affairs, Publishing, Labelling, Quality, and IT teams to enable compliance, visibility, and timely submissions across global markets.
Key Responsibilities
Collaborate with Regulatory Affairs stakeholders to gather, document, and validate business requirements for Active Dossier and Submission module enhancements.
Understand end-to-end regulatory submission lifecycle (planning, authoring, compilation, publishing, dispatch, health authority interactions, archival).
Support dossier tracking, metadata management, and controlled vocabularies within the RIM repository.
Analyze dossier data structures, registration records, and submission status to ensure accuracy, completeness, and compliance.
Define functional requirements, user stories, acceptance criteria, and test scenarios.
Monitor submission timelines, correspondence, commitments, and regulatory obligations using RIM dashboards.
Facilitate data remediation efforts to improve dossier lineage, submission sequences, and health authority metadata.
Required Skills & Experience
3–5 years of experience as a Business Analyst in Regulatory Affairs, Regulatory, or Life Sciences systems.
Hands‑on exposure to RIM platforms (AgilePV, Veeva RIM, ArisGlobal RIMS, Ennov, etc.) or equivalent regulatory systems.
Experience working with submission dossiers (eCTD/CTD), sequences, and lifecycle management.
Understanding of EMA, FDA, and ICH regulatory submission requirements.
Strong ability to translate regulatory processes into system requirements and workflows.
Experience writing user stories, functional specifications, test cases, and validation evidence.
Familiarity with controlled vocabularies (SPOR, XEVMPD, IDMP preferred).
Excellent communication and stakeholder‑facing skills.
Nice-to-Have
Prior system implementation, migration, or integration experience (RIM to EDMS, Publishing tools).
Knowledge of Registration Tracking, HA correspondence, and commitment tracking.
Ability to analyze structured data and metadata quality.
Basic understanding of IDMP data models is a plus.
Requirements/user story documentation.
Process flows and data mapping.
End‑user training assets and knowledge articles.
Seniority Level Mid‑Senior level
Employment Type Contract
Job Function Information Technology
Industries IT Services and IT Consulting and Biotechnology Research
#J-18808-Ljbffr
Look for candidates from West coast only
Pharma/ Biotech/ Life Sciences/ Medical Device/ Healthcare or Manufacturing experience is a must
Look for Veeva Business Analyst with Registration and Documentation experience.
8-10 Year candidate required
Person should understand how data is set up in registration module and how it will interact with SAP systems.
Our company is seeking an experienced Business Analyst with expertise in Veeva RIM Registrations and Integrations with SAP to join our team.
The successful candidate will be responsible for analyzing business requirements, designing solutions, and implementing changes to streamline our Veeva RIM Registration process and SAP integrations.
Responsibilities
Analyze business requirements related to Veeva RIM Registrations and SAP integrations, and identify gaps in existing processes
Design solutions and provide recommendations for process improvements related to Veeva RIM Registrations and SAP integrations
Implement changes to streamline the Veeva RIM Registration process and SAP integrations
Collaborate with cross-functional teams to develop and implement Veeva RIM Registration and SAP integration projects
Provide support and guidance to end‑users in the Veeva RIM Registration process and SAP integrations
Identify and mitigate risks related to Veeva RIM Registration and SAP integration projects
Document business processes, requirements, and system configurations related to Veeva RIM Registrations and SAP integrations
Requirements
Bachelor’s degree in business administration, Information Technology, or related field
3+ years of experience as a Business Analyst, with a focus on Veeva RIM Registrations and Integrations with SAP
Strong understanding of the Veeva RIM Registration process and experience working with Veeva Vault RIM
Role Overview The Business Analyst will support Regulatory Information Management (RIM) processes with a primary focus on Active Dossiers and the Submission Management module. The role is responsible for gathering requirements, analyzing end-to-end regulatory workflows, supporting submission lifecycle tracking, and helping ensure accurate, audit-ready data within the RIM platform. This position partners closely with Regulatory Affairs, Publishing, Labelling, Quality, and IT teams to enable compliance, visibility, and timely submissions across global markets.
Key Responsibilities
Collaborate with Regulatory Affairs stakeholders to gather, document, and validate business requirements for Active Dossier and Submission module enhancements.
Understand end-to-end regulatory submission lifecycle (planning, authoring, compilation, publishing, dispatch, health authority interactions, archival).
Support dossier tracking, metadata management, and controlled vocabularies within the RIM repository.
Analyze dossier data structures, registration records, and submission status to ensure accuracy, completeness, and compliance.
Define functional requirements, user stories, acceptance criteria, and test scenarios.
Monitor submission timelines, correspondence, commitments, and regulatory obligations using RIM dashboards.
Facilitate data remediation efforts to improve dossier lineage, submission sequences, and health authority metadata.
Required Skills & Experience
3–5 years of experience as a Business Analyst in Regulatory Affairs, Regulatory, or Life Sciences systems.
Hands‑on exposure to RIM platforms (AgilePV, Veeva RIM, ArisGlobal RIMS, Ennov, etc.) or equivalent regulatory systems.
Experience working with submission dossiers (eCTD/CTD), sequences, and lifecycle management.
Understanding of EMA, FDA, and ICH regulatory submission requirements.
Strong ability to translate regulatory processes into system requirements and workflows.
Experience writing user stories, functional specifications, test cases, and validation evidence.
Familiarity with controlled vocabularies (SPOR, XEVMPD, IDMP preferred).
Excellent communication and stakeholder‑facing skills.
Nice-to-Have
Prior system implementation, migration, or integration experience (RIM to EDMS, Publishing tools).
Knowledge of Registration Tracking, HA correspondence, and commitment tracking.
Ability to analyze structured data and metadata quality.
Basic understanding of IDMP data models is a plus.
Requirements/user story documentation.
Process flows and data mapping.
End‑user training assets and knowledge articles.
Seniority Level Mid‑Senior level
Employment Type Contract
Job Function Information Technology
Industries IT Services and IT Consulting and Biotechnology Research
#J-18808-Ljbffr