Regulatory Affairs Submissions Lead

Charlotte, NC

Industry: Regulatory & Scientific Job Number: 134595

Regulatory Affairs Submissions lead


Project Description:                                                     

Our client is currently in the process of hiring a director level regulatory affairs SME.  They need someone who can come in and act as the regulatory affairs director and assist on strategy for bringing a new product to market. The client has just finished due diligence  and are looking for someone with gene therapy experience to lead the organization throughout a submission with the FDA and health Canada. 

Day to Day Responsibilities:

This consultant will be responsible for leading the strategy and submission for a new drug to the US and Canadian Market.  This role is intended for someone who has a strong background in regulatory strategy specifically to gene therapy products.  This person must have recent experience working with the FDA on submitting gene therapy products. They will organizing meetings and being the driving force behind developing the strategy and creating the submission for the organizations new hematology product.

Required Skills:

Regulatory Affairs


Pharma Gene Therapy

Hematology product experience

Job Type: Contract

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