Associate Manager, CMC Regulatory Affairs

CMC Regulatory Affairs PositionThis position in CMC Regulatory Affairs involves the ability to support and provide some management to guide the Industrial Operations and Product Supply (IOPS) team in the decision-making process and strategic planning. This position also supports all CMC regulatory filing activities for various pre-INDs, INDs, IMPDs, CTAs and BLAs/MAAs and tracking of regulatory commitments Job Duties Essential Functions required for the job.Manage timelines in cooperation with project management, IOPS/Tarrytown SMEs and Regulatory Operations (RegOps) to ensure on-time regulatory submissions.Assist with the planning, scientific writing and perform critical reviews of a pre-INDs, INDs, IMPDs, BLAs, MAAs, annual reports, DSUR, amendments, supplements (eCTD) to ensure a high-quality regulatory submission and approval and to evaluate conformance with the regulatory requirements.Assist in regulatory inspections, as needed, at the Rensselaer site or at other sites if the inspection relates to regulatory CMC issues.Assist in review of manufacturing change controls by cross-checking the description in regulatory filings in INDs/IMPDs, CTAs and BLAs/MAAs and to ensure that manufacturing changes are reported to competent authorities in accordance with regulatory requirements.Evaluation of clinical lots to ensure they are manufactured according to the regulatory filings in the country(ies) of interest.Support establishing, managing and maintaining a knowledge base of current and emerging regulatory requirements and guidelines in the CMC field.Assist in keep track of regulatory commitments in INDs/IMPDs, CTAs, and BLAs/MAAs.Participate, as needed, in planning, organizing and managing the CMC component of Health Authority meetings.Job RequirementsExpertise in Microsoft suite (Excel, Word, PowerPoint)Strong written and verbal communication skillsStrong problem-solving and analytical skillsFamiliarity with pharmaceutical Good Manufacturing Practices and working in GMP environments preferredKnowledge of FDA and international agency regulations helpfulMinimum Years of Experience: BS/BA required; advanced degree preferred, in life sciences or related field and a minimum of 5 years (BS/BA) or 2 years (advanced degree) of related experience in CMC regulatory, and/or process/analytical science in bio/pharmaceutical industry required