Technical Consultant (Regulatory Affairs Operation)

Parexel; United States; Remote; USD 85,000 - 105,000; Full time

Job summary

Parexel is seeking a Technical Consultant for Regulatory Operations to support electronic publishing systems, validation tools, and repositories. You will work with clients and internal teams, providing expert guidance on tools used in regulatory outsourcing and ensuring system reliability.

The role offers opportunities to leverage technical consulting skills in a dynamic, client-focused environment, with exposure to global regulatory standards and best practices.

Qualifications

• Strong understanding of global regulatory submission formats and publishing standards.
• Proficiency with Windows desktop and server environments.
• Advanced Microsoft Office and Adobe Acrobat skills.
• Experience with document management systems (Documentum, EXTEDO, Lorenz, Calyx RIM, Veeva Vault).
• Fluent in English.

Responsibilities

• Provide support for electronic publishing systems and related tools.
• Assist with system validation, troubleshooting, and documentation.
• Engage with clients and internal teams to deliver solutions.
• Mentor junior staff and manage client relationships.
• Plan and deliver services to ensure client satisfaction.

Skills

Regulatory knowledge

Windows expertise

Office & Acrobat

English fluency

Troubleshooting

Client engagement

Education

Bachelor’s degree in Technology, Life Sciences, or related field

Tools

Documentum

EXTEDO

Lorenz

Calyx RIM

Veeva Vault

Job description

When our values align, there’s no limit to what we can achieve.
At Parexel, we all share the same goal - to improve the world’s health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in what we do.

Each of us, no matter what we do at Parexel, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with empathy and we’re committed to making a difference.

Technical Consultant

Regulatory Operations | Parexel

Work Schedule: 11:00 AM - 8:00 PM (Mexico Time) - MANDATORY

Role Overview

We are seeking a Technical Consultant to join our Regulatory Operations team at Parexel. In this role, you will provide comprehensive support for our electronic publishing systems, validation tools, repositories, and related components that enable regulatory operations. You will work with both external customers and internal employees, providing expert guidance on tools and systems used for regulatory outsourcing activities. This position offers an excellent opportunity to leverage your technical expertise and consulting skills in a dynamic, client-focused environment.

Key Responsibilities

System Management & Support

• Assist team with ongoing systems management activities and manage customer expectations around software functionality, stability, and maintenance
• Provide advanced troubleshooting for paper and electronic publishing systems, PDF, Word, and desktop applications
• Perform computer software setup, installation, configuration, testing, and troubleshooting
• Document work activities including system validation, troubleshooting activities, and internal work requests
• Execute publishing system validation tests following established documentation and best practices
• Maintain familiarity with current and future global regulatory submission standards and departmental best practices
• Prioritize workload and project activities to achieve project scope and objectives

Consulting & Client Engagement

• Work with clients, internal partners, and software vendors to develop and deliver solutions
• Provide guidance to project team members and mentor junior staff
• Serve as subject matter expert on important projects and leverage previous project knowledge to improve efficiency
• Plan and deliver services that result in client satisfaction and build relationships for additional business opportunities
• Facilitate resolution of technology-related problems with project teams and clients
• Interact professionally at multiple organizational levels, including senior management within client organizations

Mandatory Requirements

Technical Knowledge & Expertise

• Strong understanding of global regulatory submission formats, industry standards, guidelines, and publishing best practices
• Proficiency in Microsoft Windows desktop and server environments
• Advanced proficiency with Microsoft Office products and Adobe Acrobat
• Hands-on experience with document management systems (e.g., Documentum, EXTEDO, Lorenz, Calyx RIM, Veeva Vault)
• Fluent in English

Professional Competencies

• Advanced troubleshooting techniques for publishing systems and desktop tools
• Experience writing and executing validation and quality test scripts
• Excellent verbal and written communication skills
• Ability to manage multiple priorities with strong attention to detail
• Client-focused approach and ability to work effectively in a matrix environment
• Flexibility, teamwork orientation, and willingness to learn new technologies

Preferred Qualifications

• 3-5 years of experience in Regulatory Operations, Publishing, or Regulatory Technology support roles
• Bachelor’s degree in Technology, Life Sciences, or a related field
• Experience with software validation and quality assurance activities
• Demonstrated consulting skills and ability to mentor junior team members

What We Offer

• Opportunity to work with cutting-edge regulatory technology and publishing systems
• Exposure to global regulatory standards and best practices
• Collaborative, matrix-based environment with opportunities for mentoring and professional development
• Direct client engagement and the ability to drive meaningful business solutions
• Competitive compensation and comprehensive benefits package

Parexel is an Equal Opportunity Employer.

We celebrate diversity and are committed to creating an inclusive environment for all employees.