Relocation package

Included

Company

Cognizant Technology Solutions Hungary Kft.

Employment type

Full time

Salary

(to negotiate)

Experience

Mid Level

Individuals in this role supervise and quality control the compilation, maintenanceand updating of Regulatory Documentation and associated data in the client
Regulatory database system, documentation version control
Optimizing utilization, and effective Resource Allocation planning for the team
100% compliance for work allocation
Good Team Management (Indicated through good Skip level feedback and no major escalations)
Ensure adherence to Cognizant and Client SOPs (Standard Operating Procedure)
Responsible for regular FMEA update
Complete all mandatory training courses as applicable
Effective risk management and issue handling by conducting daily huddle and escalating them on time to time
Provides support to the following processes:
- EVMPD
- Global Labeling
- Submission Management
- Compliance Data Management
Develops and mentors the associate by providing expertise applicable to their region of responsibility
Leads a delivery team, manages people.
Coordinates and triages all work activity.
Provides input into BI processes and software to Engagement Manager for communication back to BI.
QCs work through spot checks on a regular basis.
Understands Client expectations.
Ensures training completion and compliance to applicable CTS and BI "Quality Management System"
To ensure that the PGTP is compliant as per the Project requirements & SOP for Training at Cognizant Intuitive Operation & Automation (IOA)
To ensure team is in compliance to applicable CTS and BI "Quality Management System"

Bachelor degree in life sciences/pharmacy with 3-5 years of experience in Regulatory
Affairs, PV Data handling
Electronic Regulatory Database usage
English (required actual work execution)
Good verbal and written communication skills
Knowledge of product life cycle management from regulatory perspective would be an added advantage