Regulatory CMC Manager - Large Consultancy - 12 Month Contract - Austria

Location
London
Salary
Competitive
Posted
Oct 14, 2018
Closes
Nov 12, 2018
Ref
#30105
Contract Type
Full Time
Job Type
Manager

Job Summary I am working with a large consultancy looking to expand their team with an experienced Regulatory CMC Consultant who is to come in and hit the ground running on an initial 12 Month Contract. This is a full-time role based in the London area.

Job Overview Role Responsibilities
o review local dossier against core dossier updates(Core Dossier preparation will be executed by US group)
o Discussing local market requirements with local teams
o Liaising with the CMC technical authoring team to adapt local market dossier
o Discuss additional data requirements/documentation with manufacturing and other key stakeholders
o Co-ordinate submission timings with RA Product manager.
o Support tracking of submissions and HA questions

Skills Required - 5 years CMC experience required (minimum)
- Extensive biologics experience
- Experience in working in EU & international markets

Contact Details Get in touch with Ben Chitty at ben.chitty@peoplewithchemistry.com or call on 0203 019 5951 to find out more about this opportunity. This will be 100% confidential.