Senior Manager/Director of Regulatory Affairs, Pharma
Location: Irvine, California
Our client is an industry leader in the treatment of chronic eye diseases with novel therapies that provide sustainable solutions and combination medical products. They have created first-to-market innovations, have a strong pipeline of products in development currently, and are in a new growth stage. We are partnering with them for a newly created Senior RA Manager or Director of Regulatory Affairs position to be the VP’s right-hand person while developing and implementing global regulatory strategy for drug-device combination products. This is a General role that will support preclinical, aspects of CMC, clinical and commercial development of programs.
The Right Talent:
BS in Science or BS with relevant experience/MS preferred
6+ Years of Pharma RA experience with drug development/combination products a plus
Experience with IND and NDA regulatory submissions
Knowledge of clinical study design, protocols, and CMC requirements for product development preferred
Leadership experience with direct reports is a plus
Experience with product lifecycle management or supplements is a plus
Strong cross-functional leadership experience working with other departments
This is a Hybrid role with a strong relocation package if needed and LTI/equity
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