Regulatory Affairs Business Analyst

Princeton, NJ 08540

Job Category: Information Technology Job Number: 161046

Job Description

Job Title:              Regulatory Affairs Business Analyst 

Location:               Princeton, New Jersey - 08540

Job Type:              Contract

Duration:               6+ Months

About Our Client: Our Client is a leading global professional services company, providing a broad range of services and solutions in strategy, consulting, digital, technology and operations. Combining unmatched experience and specialized skills across more than 40 industries and all business functions – underpinned by the world’s largest delivery network – Our Client works at the intersection of business and technology to help clients improve their performance and create sustainable value for their stakeholders. With approximately 425,000 people serving clients in more than 120 countries, Our Client drives innovation to improve the way the world works and lives

Job Description:

Essential Job Responsibilities:

The Business Analyst will engage and partner with cross functional business teams to gather business requirements, perform gap analysis, develop functional requirements, define solution recommendations, draft business cases, perform vendor research, partner with internal and external development and testing teams to execute the projects, and perform other related duties. The Business Analyst should be familiar with R&D operations, GxP, SDLC, Agile, and related processes. The candidate should have knowledge of Regulatory Affairs, and will report to the Director, R&D IT.

Core Responsibilities:

  • Understand and document business processes/ problems and create solutions to meet desired business outcomes.
  • Lead requirements gathering efforts (Business Process/Functional and Technical Specifications).
  • Establish SDLC and Agile release definitions in partnership with business owner for concurrent initiatives. This includes identifying scope, deliverables, timelines, and leading status meetings.
  • Translate and document non-technical requirements into technical requirements and design.
  • Educate development teams on the proposed solution to ensure effective development cycles.
  • Test developed solutions as needed and facilitate UAT with business partners.
  • Continually assess business needs and implement measures that will ensure customer expectations are met or exceeded by enhancing system capability and performance.
  • Document and track change requests and facilitate prioritization discussions with IT and business owners.
  • Generate meeting minutes, documentation, presentations and reports as needed.
  • Assist Project Manager as needed with project execution.
  • Create training materials for solutions and deliver training to end-users.


  • Bachelor’s degree is required.
  • 5+ years of experience in the R&D Pharma IT domain and work with GxP systems.
  • 2+ years of Regulatory Affairs systems related work experience.
  • An understanding of systems development lifecycle deployment methodologies is required.
  • Strong analytical and problem-solving skills is required.
  • Proficiency using Microsoft Office (Excel, Word, PowerPoint, Visio) at advanced level is required.
  • Ability to communicate effectively with all levels of the organization.
  • Up to 10% travel is required based upon business needs. 
  • Project management experience is preferred

About ASK: ASK Staffing is an award-winning technology and professional services recruiting firm servicing Fortune 500 organizations nationally. With 5 nationwide offices, two global delivery centers, and employees in 42 states-ASK Staffing connects people with amazing opportunities

Reach Out To A Recruiter

Recruiter:        Jeff Kasula


Phone:               678 -890-5105

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