Description
My client, a medium sized bio-pharmaceutical company in the Oxfordshire area,is looking for an Associate Director of Global Regulatory Affairs (CMC).
This will be open as a permanent role and working across regulatory submissions , late and early stage and leading multi-disciplinary teams in essential business projects.
Responsibilities:
-Planning and coordinating the authoring/reviewing of Module 2 (QOS) and Module 3 sections of regulatory submissions
-Provide in-depth reviews of protocols, reports, presentations and preempting internal/external business challenges or regulatory issues.
-Interpret complex technical or supply issues for commercial/development programs
-Regular interaction with functional leaders/major customers
-Development of departmental strategy
-Monitor EU and US CMC Regulations
Candidate Profile:
- Applicable knowledge of CMC regulatory
- eCTD CMC regulatory documents (MAA, BLA, Variations, Responses, CTAs/INDs)
- FDA, EMA and ICH guidelines
Education:
- BSc/BA with a minimum of eight years of regulatory CMC experience
If this role may be of interest and you feel you have a suitable profile, please do apply and get in touch with Ross Wilson at rwilson@keypeople.co.uk
