Philadelphia, Pennsylvania, 19107

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Full Time
Onsite
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(Executive) Director, Regulatory Affairs, CMC

Job description

The Director/Executive Director is responsible for spearheading the global regulatory chemistry, manufacturing, and controls (CMC) strategy and implementation for cell and gene therapy initiatives from the initial development phase to product licensing. This role involves acting as the main point of contact with regulatory agencies and managing the creation of CMC documentation for regulatory filings. Applicants should hold a bachelor’s degree in a life sciences or engineering field, along with a minimum of 10 years of regulatory CMC expertise within the biotech or pharmaceutical sector. Experience in cell therapy or viral vector production, coupled with a comprehensive understanding of FDA and ICH guidelines, is essential.


Dispatch Bio provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws.
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