Achillion Pharmaceuticals is seeking a Director of Regulatory Affairs Chemistry, Manufacturing, and Controls (CMC) to join our growing team in the Blue Bell, Pennsylvania office. Reporting to the Head of Global Regulatory Affairs, the incumbent will have a critical role in the department with responsibility for all CMC-related strategy, development, and oversight supporting the corporate objectives. The incumbent will partner closely with senior leadership in Pharmaceutical Science, Global Regulatory Affairs, Quality & Compliance, and other key functional areas, as well as external partners and Contract Manufacturing Organizations (CMO), to drive successful global regulatory development and registration strategies for all Achillion assets.
The Director of Regulatory Affairs CMC will work closely within a team and be responsible for assuring compliance with Good Manufacturing Practices (GMPs), drafting, authoring, reviewing, and submitting key regulatory documents including Investigational Medicinal Product Dossier (IMPD), CMC sections of Investigational New Drug Applications (INDs), New Drug Applications (NDAs), Clinical Trial Applications (CTAs), Marketing Authorization Applications (MAAs), and other documents as needed. The incumbent will also represent Achillion at global health authority meetings where CMC matters/topics are being discussed including those with the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA), and others as required. The incumbent will also have responsibility for working with both internal and external stakeholders to ensure inspection readiness and preparedness at both Achillion and CMO facilities.