Regulatory CMC Manager - Large Consultancy - 12 Month Contract - Austria
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 email@example.com or call on 0203 019 5951 to find out more about this opportunity. This will be 100% confidential.