Regulatory Publishing Consultant (Regulatory Systems SME)

Parexel

Parexel is a leading global clinical development partner delivering insights-driven clinical and consulting solutions to the life sciences industry. With 22,000+ employees worldwide, we partner with biopharmaceutical companies and research sites to design and deliver patient-focused clinical trials that broaden access and make research a care option for anyone, anywhere.

We work with focus, agility, and shared purpose -- moving with urgency to address patient needs and accelerate the delivery of new therapies. We embrace bold thinking, adapt quickly to change, and continually raise the bar for the speed and quality of clinical research. We are expanding our team and seeking talented individuals to help drive industry-leading innovation, With Heart(R).

About the Role

Parexel is seeking a Regulatory Publishing Consultant (Regulatory Systems SME) 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.
• Bachelor's degree in Life Sciences, Technology, Computer Science, Pharmacy, Regulatory Affairs, or a related field.
• Due to the global nature of our team, this role requires the ability to work from 2pm ET-10pm ET

Preferred Qualifications

• 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

If this job doesn't sound like the next step in your career, but perhaps you know of someone who'd be a perfect fit, send them the link to apply!

We believe in flexibility, growth, and creating space for people to do their best work. Join us and be part of a team where your contributions help shape the future of clinical research.

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