Known for its scientific and operational excellence, Regeneron is a leading science-based biopharmaceutical company that discovers, invents, develops, manufactures, and commercializes medicines for the treatment of serious medical conditions. Regeneron commercializes medicines for eye diseases, high LDL-cholesterol, and a rare inflammatory condition and has product candidates in development in other areas of high unmet medical need, including oncology, rheumatoid arthritis, asthma, atopic dermatitis, pain, and infectious diseases.
Summary: Maintain active engagement with emerging and current regulatory trends in the industry and act in a consultative capacity to our Industrial Operations and Product Supply and clinical regulatory affairs as related decisions and processes are executed. Support all CMC regulatory filing activities for various pre-INDs, INDs, IMPDs, CTAs and BLAslMAAs and track regulatory commitments.
Essential Duties and Responsibilities include, but are not limited to, the following:
* Manage timelines in cooperation with project management, Operations, SMEs and Tarrytown Regulatory Operations (RegOps) to ensure on time regulatory submissions.
* Assist with the planning, scientific writing and perform critical reviews of preINDs, INDs, IMPDs. BLAs, MAAs, annual reports, DSUR, amendments, supplements to ensure a high quality regulatory submission and approval
* Ensure that all regulatory submissions are of highest regulatory standards.
* Coordinate and manage 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 BLAslMAAs and to ensure that CMC related changes are reported to competent authorities in accordance with regulatory requirements.
* Support establishing, managing and maintaining a knowledge base of current and emerging regulatory requirements and guidelines in the CMC field.
* Assist in tracking of CMC regulatory commitments for INDsIIMPDs, CTAs, and BLAslMAAs.
* Participate, as needed, in planning, organizing and managing the CMC component of pre-IND and preBLA meetings with FDA
* Support Ops by providing CMC related guidances so that their short-term and long-term goals are achieved on time and with highest quality.
* Participate in CMC project team meetings and provide current regulatory requirements that pertain to stability studies and analytical characterization tests.