Regulatory Affairs Associate

Reg Ops: Publishing, QC

• Understanding of global regulatory submission formats, industry standards, and guidelines, software validation concepts, and publishing best practices.

• Proficient in Microsoft Windows desktop and server environments; Microsoft Office products; Adobe Acrobat and plug-ins; Documentum and/or other document management systems; PAREXEL LIQUENT InSight and SmartDesk product lines.

• Employs advanced troubleshooting techniques to efficiently address publishing system and desktop tool issues.

• Experience with executing validation and quality test scripts

• Ability to learn new technology and apply to business needs.

• Excellent interpersonal, verbal and written communication skills

• Client focused approach to work

• A flexible attitude with respect to work assignments and new learning

• Ability to manage multiple and varied tasks with enthusiasm and prioritize workload with attention to detail

• Willingness to work in a matrix environment and to value the importance of teamwork

QualificationsBachelor’s degree or equivalent in technology or life sciences-related discipline