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PRMS Architect
Job
Wise Skulls
Flower Mound, TX (In Person)
Full-Time
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Job Description
PRMS Architect at Wise Skulls PRMS Architect at Wise Skulls in Flower Mound, Texas Posted in about 3 hours ago.
Type:
full-timeJob Description:
Hiring:
PRMS Architect | United States | Flower Mound (TX), Irvine (CA), Mahwah (NJ), Portage (MI) We're looking for an experienced PRMS Architect with strong expertise in Regulatory Information Management Systems (RIMS/PRMS), regulatory submissions, compliance, and enterprise integrations to join a high-performing pharmaceutical transformation team.Location:
Flower Mound (TX), Irvine (CA), Mahwah (NJ), Portage (MI)Duration:
6 Months (Possibility of Extension)Implementation Partner:
Infosys End Client:
To be disclosed (Pharma)Key Responsibilities & Skills:
- Lead the architecture, design, and implementation of Product Registration and Regulatory Information Management Systems (PRMS/RIMS)
- Define scalable regulatory solutions aligned with global compliance requirements including FDA, EMA, MHRA, and ASEAN regulations
- Design and manage end-to-end product registration lifecycle processes, including submissions, approvals, renewals, and variations
- Architect and oversee integrations between regulatory systems and enterprise applications such as ERP, document management, and quality systems
- Integrate
PRMS/RIMS
platforms with SAP, Oracle, QAD, Veeva Vault, and other enterprise platforms- Ensure compliance with GxP, 21 CFR Part 11, audit trail requirements, computerized system validation (CSV), and data integrity standards
- Establish regulatory data governance frameworks and master data management strategies
- Lead vendor evaluations, solution selection, implementation, and global deployment initiatives
- Collaborate with regulatory affairs, quality, compliance, and IT teams to align technology solutions with business objectives
- Provide technical leadership and best practices for regulatory systems architecture and governance
Mandatory Skills:
- Strong experience with RIMS, PRMS, Veeva Vault RIM, or similar regulatory platforms
- Deep understanding of CTD and eCTD regulatory submission processes and workflows
- Expertise in product registration lifecycle management
- Strong knowledge of global regulatory compliance requirements (FDA, EMA, MHRA, ASEAN)
- Experience with GxP compliance, CSV validation, and data integrity practices
- Hands-on experience integrating regulatory systems with ERP and document management platforms
- Strong understanding of regulatory data governance and master data management
- Excellent stakeholder management, communication, and leadership skills
What We're Looking For:
A highly skilled PRMS Architect who can lead enterprise regulatory systems initiatives within the pharmaceutical industry. The ideal candidate will possess deep expertise in regulatory information management, global submission processes, compliance frameworks, and enterprise integration strategies while driving successful global implementations and regulatory transformation programs.Preferred Qualifications:
- 10+ years of experience in the Pharmaceutical or Life Sciences industry
- Experience with Veeva Vault RIM implementations and regulatory transformation programs
- Expertise in global regulatory submission standards and health authority requirements
- Experience leading global system rollouts and multi-region implementations
- Strong knowledge of regulatory operations, product lifecycle management, and compliance processes
- Bachelor's or Master's degree in Life Sciences, Computer Science, Information Technology, or a related field
- Experience working in regulated GxP environments Interested?