Senior Regulatory Affairs Associate

Reg Affairs & Reg Ops for pharma & vaccines: Lifecycle, Renewals, MRP, DCP Core packages

• 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.

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

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

• Experience with executing validation and quality test scripts

• 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 client

Must be able to communicate with other stakeholders- internal and external

Good at handling publishing tools - preferred to have Insight Publisher exposure. Expereince with other tools is added advantageQualificationsBachelor’s degree or equivalent in technology or life sciences-related discipline