CMC Regulatory Affairs Manager - LCM

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 Lifecycle Management CMC Regulatory Affairs Senior Manager. The candidate who would fit this role would be someone skilled in the below :

• Experienced CMC author with expertise in EU / US product lifecycle variations
• Lead EU / US LCM strategy and submission preparation.
• Lead engagement with regulatory agencies and commercial partners
• You have written CMC Documentation relating to Analytical Development (Method Changes / Validation / Stability design etc)
• Ability to make decisions on what information to include into a document and what you can remove for a smoother submission.