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Are you ready to make your mark in the healthcare industry using your ingenuity and technical expertise? At Parexel, there's no limit to what you can accomplish. We work with the top 50 global pharmaceutical companies, the top global biotech companies, and hundreds of small and emerging companies. We've supported the development of some of the most important treatments of our time, including nearly all of the 50 top selling drugs currently on the market. Join us and you'll make a profound difference in millions of lives. With a role in our Information Technology group, you'll work with cutting-edge technology on internal and client-facing projects. Collaborating with people from all over the world and touching everything from enterprise systems and clinical applications to infrastructure and networking, you'll keep our data safe and confidential. You'll have the chance to develop your skills and pursue advancement opportunities that include managerial and technical tracks. If you have stellar coding and design experience and a passion to learn more about healthcare, Parexel invites you to discover our rewarding opportunities in Enterprise Architecture, Software Development, Project Management and Business Analysis, and more. In a global clinical trial environment, business-focused applications, connectivity, and data security are critical to a trial's outcome. Find out how you can be an invaluable part of our success story.
Regulatory Operations Technical Consultant (eCTD Publishing & Regulatory Systems)
Job ID R0000044309 , MexicoTechnical Consultant, Regulatory Operations (eCTD Publishing & Regulatory Systems) - Remote
Location: Mexico (Candidates located in other countries cannot be considered)
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
- Global 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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