Technical Consultant, Regulatory Publishing (eCTD Publishing & Regulatory Systems) - Remote
Primary Location: Mexico
Secondary locations: Colombia, Chile, Perú

Work Schedule
11:00 AM to 8:00 PM (Mexico Time) This schedule is mandatory due to collaboration with global teams and stakeholders.

About the Role
Parexel is seeking a Technical Consultant to join our Regulatory Operations team. In this role, 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, execute validation activities, and ensure the effective use of publishing and regulatory information management solutions.

This position is ideal for professionals with experience in Regulatory Operations, eCTD Publishing, Regulatory Technology, or Regulatory Systems Support who enjoy combining technical problem-solving with client-facing consulting responsibilities.

What You Will Do
Regulatory Systems & Publishing Support

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.

Consulting & Client Engagement

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.

Required Experience & Qualifications
Must-Have Experience

3+ years of experience in:

Regulatory Operations

Regulatory Publishing

eCTD Submission Management

Regulatory Technology Support

Regulatory Information Management (RIM)

Experience supporting or using one or more of the following platforms:

Veeva Vault RIM

Documentum

EXTEDO

Lorenz

Calyx RIM

Similar regulatory publishing or document management systems

Strong understanding of:

eCTD submissions

Regulatory publishing processes

Integral regulatory submission standards

Submission lifecycle management

Experience performing:

System troubleshooting

Software testing

Validation activities

User support





Advanced proficiency with:

Microsoft Office Suite

Adobe Acrobat

Windows operating systems

Fluent English communication skills, both written and verbal.

Preferred Qualifications

Bachelor's degree in Life Sciences, Technology, Computer Science, Pharmacy, Regulatory Affairs, or a related field.

Experience writing and executing validation protocols and test scripts.

Experience working within a CRO, pharmaceutical, biotechnology, or regulatory technology environment.

Prior client-facing or consulting experience.

Experience mentoring team members or acting as a subject matter expert.

Success in This Role
You will be successful if you have hands‑on experience with regulatory publishing technologies and enjoy solving technical challenges while working closely with clients and cross‑functional teams. Candidates with backgrounds in eCTD Publishing, Regulatory Operations, Regulatory Systems, Veeva Vault RIM, Documentum, EXTEDO, or Regulatory Technology Support are strongly encouraged to apply.

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.

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📌 Regulatory Publishing Technical Consultant (Regulatory Systems) (Colón)
🏢 Parexel International
📍 Colón