Regulatory Solutions Architect

  • Posted 21 hours ago | Updated 21 hours ago

Overview

Remote
Depends on Experience
Contract - Independent
Contract - W2
No Travel Required

Skills

Certification in Regulatory Affairs (RAC)
Certification enterprise architecture (TOGAF)
AI/ML
IDMP
xEVMPD
and structured content authoring
commercial or medical affairs systems

Job Details

Role : Regulatory Solutions Architect
Duration: Long Term
Location: Remote | On W2
Job Summary:
We are seeking an experienced Regulatory Solutions Architect with a strong background in Commercial Regulatory Affairs to lead the design and implementation of technology solutions that support global regulatory operations. This role bridges the gap between business and IT, ensuring regulatory compliance and operational efficiency through scalable and compliant digital solutions.
Required Qualifications:
  • Bachelor s or Master s degree in Computer Science, Regulatory Affairs, Life Sciences, or a related field.
  • 7+ years of experience in Regulatory IT or Regulatory Affairs, including 3+ years as an Architect or Lead.
  • Proven experience working with Commercial Regulatory Affairs systems (e.g., labeling, promotional compliance, Veeva PromoMats, MedComms).
  • In-depth knowledge of regulatory requirements in US, EU, and global markets.
  • Strong understanding of regulatory data models and integration strategies across RIM, ERP, and MDM platforms.
  • Experience with cloud-based Regulatory systems and platforms, especially in the Veeva ecosystem.
  • Excellent communication skills and ability to interact with senior stakeholders and regulatory teams.
Preferred Qualifications:
  • Certification in Regulatory Affairs (e.g., RAC) or enterprise architecture (e.g., TOGAF).
  • Experience with AI/ML solutions applied to regulatory use cases.
  • Familiarity with IDMP, xEVMPD, and structured content authoring.
  • Background in commercial or medical affairs systems.
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