Athersys seeks an experienced regulatory manager to ensure company-wide compliance with FDA regulations. This individual will take a leading role in the development of a regulatory strategy through interpreting regulatory agency policies, procedures and regulations as applied to company programs; anticipating regulatory concerns to ensure regulatory readiness; facilitating, negotiating and resolving compliance issues with regulatory agencies; and managing the preparation of accurate and appropriate regulatory submissions consistent with established regulatory policies and procedures. Responsibilities include drafting and approving SOPs, clinical protocols, labeling and advertising for programs and products; coordinating quality assurance and personnel training; overseeing the records/documentation system and personnel; and facilitating FDA and other audits to ensure quality and compliance. 

5-7 years of comprehensive regulatory/quality experience in the biotechnology, pharmaceutical or medical products industry. Extensive/working knowledge of FDA and quality system regulations and proven negotiating skills. Experience in document management systems. A bachelors degree or higher in scientific, engineering or quality assurance discipline.

Project management and supervisory experience with a demonstrated ability to work effectively in cross-functional teams as well as individually. Technical knowledge of molecular and/or cellular products and processes preferred.