Regulatory Publishing Tech Consultant

Parexel; United States; Hybrid; USD 90,000 - 130,000; Full time

Benefits offered by this job

Comprehensive benefits

Direct client engagement

Mentoring and professional development

Job summary

Parexel is seeking a Technical Consultant to join our Regulatory Operations team. You will serve as a subject matter expert for regulatory publishing systems, document management technologies, and electronic submission tools used to support global regulatory activities.

You will partner with internal teams, software vendors, and external clients to provide technical support, troubleshoot complex issues, and ensure effective use of publishing and regulatory information management solutions.

Qualifications

• 3+ years of experience in Regulatory Operations, Regulatory Publishing, eCTD Submission Management, Regulatory Technology Support, or Regulatory Information Management.
• Experience with one or more platforms such as Veeva Vault RIM, Documentum, EXTEDO, Lorenz, Calyx RIM or similar systems.
• Strong understanding of eCTD submissions, regulatory publishing processes, and global submission standards.

Responsibilities

• Provide technical support for regulatory publishing and submission management systems.
• Troubleshoot issues related to eCTD publishing tools, document management systems, PDF creation, Microsoft Office applications, and desktop environments.
• Configure, install, test, validate, and maintain regulatory technology solutions.
• Support system validation activities, execute test scripts, and document results.
• Maintain compliance with regulatory submission standards, publishing guidelines, and industry best practices.
• Manage multiple priorities while ensuring high-quality deliverables and service levels.
• Partner with clients, regulatory teams, and software vendors to resolve technical challenges and deliver effective solutions.
• Act as a trusted advisor on publishing technologies and regulatory systems.
• Support project teams by sharing expertise and mentoring less experienced team members.
• Participate in client meetings and provide recommendations to improve efficiency and system utilization.
• Build strong relationships with internal and external stakeholders while ensuring client satisfaction.

Skills

Regulatory Operations

Regulatory Publishing

eCTD Submission Management

Regulatory Technology Support

Regulatory Information Management

Microsoft Office

Adobe Acrobat

Windows OS

Fluent English

Education

Bachelor’s degree in Life Sciences or related field

Tools

Veeva Vault RIM

Documentum

EXTEDO

Lorenz

Calyx RIM

Job description

Parexel is seeking a Technical Consultant to join our Regulatory Operations team. You will serve as a subject matter expert for regulatory publishing systems, document management technologies, and electronic submission tools used to support global regulatory activities.

You will partner with internal teams, software vendors, and external clients to provide technical support, troubleshoot complex issues, and ensure effective use of publishing and regulatory information management solutions.