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Precigen is a dedicated discovery and clinical stage biopharmaceutical company advancing the next generation of gene and cell therapies using precision technology to target the most urgent and intractable diseases in our core therapeutic areas of immuno-oncology, autoimmune disorders, and infectious diseases.
Precigen has developed novel manufacturing processes to deliver UltraCAR-T® and AdenoVerse™ immunotherapies to patients. We have multiple products being evaluated in the clinic using our innovative manufacturing approach to cell and gene therapies.
We are seeking a global Executive Director, Regulatory Affairs, Cell Therapy (level determined by candidate experience) reporting into the SVP Clinical Operations who will serve as the strategic lead representing regulatory affairs expertise managing the strategy and operational aspects of all regulatory submissions (INDs, NDAs, MAAs, etc.). This person will provide regulatory leadership and strategy on cross functional sub teams and advise on best practices providing relevant guidance and regulation including precedence. The Executive Director, Regulatory Affairs will also be responsible for the management and development of the team members reporting into him/her.
This role is responsible for defining regulatory strategy, planning and the preparation of US and global regulatory submissions to achieve timely approvals of initial biologic licensing and marketing authorization applications and post-approval lifecycle changes for Precigen’s CAR-T Products.
This position will be onsite in Germantown, Maryland.
#LI-ONSITE #LI-AZ1
Full Time
Religious Organizations
$198k-269k (estimate)
04/01/2024
05/30/2024
precigen.com
FLANDREAU, SD
500 - 1,000
1998
Public
TODD HONKOMP
$50M - $200M
Religious Organizations
Precigen is a pharmaceutical company that develops gene and cellular therapies for the treatment of immuno-oncology and autoimmune disorders.