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Senior Manager/Director of Regulatory Affairs, Pharma

Location: Irvine, California
Reference ID:

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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