Regulatory Affairs Manager - CMC
CMC expert sought (ICH, FDA and EMA)
Experience of eCTD submissions required
About Our Client
Our client is a Life Sciences organisation with focus on multiple Therapeutic areas based in Thames Valley
Regulatory Affairs Manager - CMC is required to:
- Ensure continued compliance to regulations for existing products
- Manage CMC document lifecycle and electronic publishing
- Ensure regulatory submissions for CMC is written and reviewed
- Represent internally for all CMC regulatory matters
The Successful Applicant
To be considered for the Regulatory Affairs Manager - CMC position the following is required:
- Experience gained in CMC Regulatory Affairs at Manager level.
- Experience of FDA, IHC and EMA.
- Experience of eCTD
What's on Offer
Contract opportunity -Possible temp to perm.