Regulatory Business Analyst

Overview

On Site
$70 - $80
Contract - W2
Contract - Independent

Skills

Regulatory
eCTD
CMC
Regulatory Information Management System
Chemistry
Manufacturing & Controls

Job Details

About Nexinfo:

NexInfo is a consulting firm focused on improving business processes and automation in the Supply Chain and Product Lifecycle Management sectors. They offer services in business process design, software implementations, managed services, staff augmentation, and SaaS solutions. The company aims to help businesses across industries achieve their goals through industry best practices, lean process design, and advanced software solutions. Their ERP-related services address challenges such as inventory management, product lifecycle management, demand management, forecasting, sales and operations planning, business intelligence, security compliance, and financial alignment.

Job Title: RIM Business Analyst

Location: Foster City CA (Hybrid)

Type: Contract

About the Role

We are seeking an experienced Lead Business Analyst with strong exposure to eCTD 4.0, Regulatory, and CMC (Chemistry, Manufacturing & Controls) data processes. This role will focus on analyzing how eCTD 4.0 impacts CMC data, understanding evolving regulatory requirements, and supporting system readiness and optimization. The ideal candidate will bridge the gap between business needs and technology solutions in the regulatory domain.

Key Responsibilities

  • eCTD 4.0 Readiness
    • Analyze how eCTD 4.0 will impact CMC data structures and processes.
    • Define and document new requirements to align with eCTD 4.0 standards.
    • Work closely with Regulatory Affairs and CMC teams to ensure submission readiness.
  • Business Analysis & Process Mapping
    • Conduct current state assessment of CMC and Regulatory data systems.
    • Identify gaps, risks, and improvement opportunities in current processes.
    • Develop future-state process models and functional requirements.
  • Stakeholder Engagement
    • Lead cross-functional workshops with Regulatory, CMC, IT, and Data Governance teams.
    • Translate complex regulatory requirements into actionable system and data requirements.
    • Communicate project updates to stakeholders and leadership.
  • System Evaluation & Implementation Support
    • Evaluate and recommend system changes or enhancements required to support eCTD 4.0.
    • Partner with technical teams for solution design and validation.
    • Support UAT (User Acceptance Testing) and training for impacted users.
  • Leadership
    • Lead and mentor a small team of Business Analysts working on regulatory data initiatives.
    • Act as a Business Analyst lead for eCTD 4.0 and CMC data readiness streams.

Qualifications

  • 7+ years of Business Analyst experience in Pharmaceutical or Biotech industry.
  • Proven experience with Regulatory Affairs and CMC processes.
  • In-depth understanding of eCTD submission process (eCTD 3.2.2 and 4.0 preferred).
  • Strong experience in Regulatory Information Management (RIM) and Document Management Systems (DMS).
  • Familiarity with CMC data management and structured content authoring is a plus.
  • Experience leading cross-functional teams and Business Analysts.
  • Excellent communication, facilitation, and stakeholder management skills.

Preferred Tools / Knowledge

  • RIM Systems (e.g., Veeva Vault RIM, Lorenz, Ennov)
  • CMC Data Repositories / PLM Systems
  • ICH M4 / eCTD standards and guidance
  • Familiarity with IDMP and structured data submissions is a plus.

Thanks & Regards,

Joseph Thambi
Senior Executive - Talent Acquisition

Employers have access to artificial intelligence language tools (“AI”) that help generate and enhance job descriptions and AI may have been used to create this description. The position description has been reviewed for accuracy and Dice believes it to correctly reflect the job opportunity.