Regulatory Affairs - Senior CMC Officer
Up to £50,000
Senior CMC Officer opportunity working for a rare disease biotech based in Hertfordshire. The business works across immunology, critical care and Coagulation Disorders and are looking for a Senior CMC Officer to support its CMC team.
As a Senior CMC Officer you will be responsible for driving the generation of appropriate and well-controlled technical documents maximizing the chances of first-time approval, and minimizing the need for change applications.
- Liaise early on with R&D, Production, Quality, Engineering and Validation to think through what would constitute a solid CMC data package with focus on reducing testing and in-process controls to what is necessary and sufficient.
- Assist in review of manufacturing change controls by cross-checking the description in regulatory filings in INDs/IMPDs, CTAs and BLAs/MAAs for specific, or complex changes
- Develop standards to ensure good technical documents and speedy approvals due to reduction in requests for clarification and repeat questions while building knowledge of regulatory requirements and regulatory procedures to obtain new licenses and maintain existing licenses.
- Bachelor’s degree or higher in Life Sciences or technical field and around 4 years of experience in pharmaceuticals or a related industry. Advanced degree preferred.
- In-depth knowledge of cGMPs (MHRA, US, EU,) for biologics and preferably plasma.
- Knowledge of biologics manufacturing compliance.
- A love for CMC and a hands-on attitude.
The role is an excellent opportunity to work on complex biologics within an innovative environment. This opportunity allows for great career progression opportunities as well as the opportunity to work remotely with the occasional meeting in the office-based in Hertfordshire. The role also includes a 10% bonus, private health insurance, pension, life insurance, and 25 days holiday.
If you are interested in this role or would like more details please email your CV to firstname.lastname@example.org