Regulatory Affairs Submissions Lead
Regulatory Affairs Submissions lead
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.
Pharma Gene Therapy
Hematology product experience
Job Type: Contract