Job type
ContractLocation
LondonWorking Pattern
Flexible Working,Full-timeSpecialism
Regulatory AffairsIndustry
Scientific and R&DPay
£650 - £725 Ltd Co rateClosing date
21 Jul 2024
Regulatory affairs, CMC, Biologics, outside IR35, contract job
Regulatory Affairs Consultant CMC, biologics outside of IR35
Your new company
This growing US rare disease company is looking for an experienced Regulatory Affairs CMC (biologics) professional to join them on a 12-month contract, this contract job is outside of IR35 and can be fully remote or hybrid working.
Your new role
As Regulatory Affairs Consultant CMC, biologics (outside of IR35) you will be responsible for providing Regulatory CMC support for post-approval submissions for commercial products, predominantly biotechnology products and new international MAA filings predominantly in EMEA region.
What you'll need to succeed
In order to be considered for this out of scope Regulatory Affairs CMC contract job, you must have experience of generating global regulatory strategy documents, proven ability to lead SME team of authors to generate variation/supplement content enabling Right First Time approvals, good knowledge of regulatory legislation and CMC guidance in EU, US and ICH markets, experience with international MAA and post-approval filings essential, good knowledge of regulatory submissions for biotech products, experience with Agency interaction preferred
What you'll get in return
Option for working fully remotely or hybrid working
What you need to do now
For more information on this or any other Regulatory Affairs contract jobs, please apply for this advert.
If you're interested in this role, click 'apply now' to forward an up-to-date copy of your CV, or call us now.
If this job isn't quite right for you but you are looking for a new position, please contact us for a confidential discussion about your career.
