Regulatory Affairs Expert - Project Manager MAA

Job type:
on-site
Start:
09/2018
Duration:
12 months
Place:
Switzerland
Date:
08/23/2018
Country:
flag_no Switzerland

Project description:
Warning
This project is archived and not active any more.
You will find vacant projects in our project database.
We are looking for a Regulatory Affairs Expert for a project to oversee, manage, advise and coordinate the implementation of a new Regulatory Information Management system for regulatory affairs submissions according to the required standards.

Tasks:
Management of product data from different sources and converting those into a new IT system in a structured format, by extracting and migrating relevant information into the new system.

Advising teams how to improve submission process by using the new system and what practise has to be implemented to achieve the objectives,

liaising with other departments and coordinating the quality of information which has to be presented to HA for successful submission,

acting as a leader and mentor to other teams and team members,
Requirements:

Prior regulatory affairs experience in particular in MAA ( CP, MRP, DP, NP)

Experience with submission to EU Authority,

Knowledge and experience of regulations and procedures

Knowledge and experience of electronic submissions tools and processes

This is 12 months contract based on site in Switzerland

Please send your CV

Michael Bailey International is acting as an Employment Business in relation to this vacancy.