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 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). 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.

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.

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.

Regulatory

Operations ~ Regulatory Publishing ~ Regulatory Technology Support ~ Regulatory Information Management (RIM) Documentum Similar regulatory publishing or document management systems Regulatory publishing processes Global regulatory submission standards Software testing Microsoft Office Suite 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.

Experience writing and executing validation protocols and test scripts.

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

Chance to work with cutting-edge regulatory technology and publishing systems Exposure to global regulatory standards and best practices Join us and be part of a team where your contributions help shape the future of clinical research. #

📌 Regulatory Publishing Technical Consultant (Regulatory Systems) (Toronto)
🏢 Parexel
📍 Toronto