Director, Regulatory Affairs
Precigen, Inc., a wholly owned subsidiary of Intrexon Corporation, is looking for a passionate and committed professional with a proven track record of success managing or directing regulatory affairs that is ready to step up to the next level as our Director, Regulatory Affairs. This role will assist with the identification of key strategic regulatory drivers for early and late stage programs for submissions (from IND to BLA.) The Director, Regulatory Affairs will be responsible for developing, establishing and maintaining effective relationships with regulatory agencies, especially the FDA and assessment of emerging data against aspirations and updating senior management on project risks/mitigation activities.
Location:Germantown, MD, Onsite Work Requirement
Job Type:Full Time
Education:Master’s or Ph.D. in Molecular Biology, Pharmaceutical Sciences or Life Sciences
Experience:A minimum of 5 years regulatory experience in biotech programs within the FDA, industry or combination