Description
A leading Bio-pharmaceutical company with a broad and exciting portfolio are currently looking for a senior CMC Regulatory Affairs Specialist.Candidate criteria;
*Proven significant experience in the biological field
*In-depth knowledge of EU regulatory requirements
*Strong Regulatory writing experience and familiarity of eCTD formats and publishing support functions
* At least 5 years experience in the preparation and submission of CMC fillings in US, European or EX-US content.
Job role;
*PrepareCMC sections of regulatory submissions
*Participate in development of regulatory strategy for new variations
*Participate in analysis activities
*Lead submissions of CMC dossiers
If you would like more details please give Akeel a call on .
Alternatively if you know someone who may be interested please pass on these details. Any referral that leads to placement is entitled to £200 vouchers.
To find out more about Real please visit www.realstaffing.com
Real Staffing, a trading division of SThree Partnership LLP | Registered office | 1st Floor, 75 King William Street, London, EC4N 7BE, United Kingdom | Partnership Number | OC387148 England and Wales