Regulatory Solutions Architect

Ingenworks; New Jersey; Remote; USD 120,000 - 150,000; Full time

Job summary

A leading company is seeking a Regulatory Solutions Architect to bridge business and IT, ensuring compliance and efficiency through scalable digital solutions. The ideal candidate will have extensive experience in Regulatory Affairs and strong communication skills.

Qualifications

• 7+ years of experience in Regulatory IT or Regulatory Affairs.
• 3+ years as an Architect or Lead.

Responsibilities

• Lead design and implementation of technology solutions for regulatory operations.
• Ensure regulatory compliance and operational efficiency.

Skills

Communication

Regulatory Affairs

Cloud-based Systems

Education

Bachelor’s or Master’s degree in Computer Science

Bachelor’s or Master’s degree in Regulatory Affairs

Bachelor’s or Master’s degree in Life Sciences

Tools

Veeva PromoMats

MedComms

Job description

Role: Regulatory Solutions Architect

Location: Remote

Duration: Long Term

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 supporting global regulatory operations. This role bridges 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 related field.
• 7+ years of experience in Regulatory IT or Regulatory Affairs, including 3+ years as an Architect or Lead.
• Proven experience 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.

Additional Information:

• Seniority level: Mid-Senior level
• Employment type: Full-time
• Job function: Engineering and Information Technology
• Industries: Software Development