Requirements: English
Company: Discover International
Region: Madrid , Community of Madrid
This is a new hire for a company who has over 10 years experience in Biologics focusing on producing therapies using antibodies. Looking at Oncology, Infectious Disease and Haematology, this company strives to offer the best antibody based medicine to patients globally.
They are hiring for an experienced CMC Regulatory Affairs Senior Manager. The candidate who would fit this role would be someone skilled in the below:
CMC specialist in Drug Product development and manufacturing of injectable biologics (e.g., vials, prefilled syringes, auto injectors). Lead US (BLA) & EU (MAA) CMC strategy & authoring for drug development through to commercialization worldwide. Lead engagement with regulatory agencies and commercial partners.