We have unique opportunities and are always looking for exceptional talent. Join a company where you will have an opportunity to grow professionally and personally and give strength to others by Empowering Healing. The individual in this role manages and develops regulatory strategies for IND submissions to FDA as well as the overall BLA submission strategy. Key Responsibilities include: Responsible for regulatory submissions for bio-technology products including cell-based and tissue derived products. Includes preparation writing and submission of IND, IND Amendments, and BLAs. Ensure that regulatory submissions are complete, properly formatted, and comply with applicable regulatory requirements.
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