Senior Regulatory Affaris Associate

Works effectively within a team environment but may work independently delivering services within their area of competence

Must be able to work independently on submissions, mentor publishers and proactively takes up publishing and related activities

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

Responsible for compiling, publishing and QC of regulatory submissions

Has previous experience of publishing high quality submissions in eCTD, NeeS and pCTD formats

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.

Works within broad project guidelines as directed by the project lead and/or technical SMEs

Takes initiative to prioritize work to achieve specified project outcomes while confirming alignment with project lead and line manager

Capitalizes on opportunities to improve one’s own performance and seeks feedback from the project lead and colleagues

Applies information provided by the project lead or senior colleagues to complete assigned project activities

Produces quality work that meets the expectations of project lead and the clientQualificationsBPharma, MPharma or any Life science related qualification