Director Regulatory CMC Posted November 21, 2008 8-10  Years Experience Summit New Jersey

JOB DESCRIPTION: Responsible for the development of the CMC regulatory strategy for submissions.  These submissions include IND/CTA/BLA, NDA, CTD and MAA regulatory filings. Coordinate the preparation and review CMC submission documents, registration dossiers, and responses to health authorities with other relevant line functions. Responsible for the regulatory evaluation of CMC change controls. Responsible for the management of CMC activities related to specific developmental or commercial compounds. Represent Regulatory CMC on CMC development/commercial and Regulatory Affairs teams.  In addition Take on leadership role in the CMC development/commercial teams. Interact with regulatory agencies and represent CMC at regulatory agency meetings. JOB REQUIREMENTS: Skills/Knowledge Required: Must have experience with CMC regulatory documents (NDA, MAA, CTD, BLA, supplements, responses and IND/CTAs) Experience in the development of CMC regulatory strategy Knowledge of FDA, EMEA and ICH guidelines. Knowledge of rest of world post approval guidelines Have a solution-oriented approach to problem solving Expertise in either the drug development process or post approval activities Ability to work on complex projects and within cross-functional teams Prior supervisor or project management experience Experience with CMC regulations for biological compounds.