Director, CMC Regulatory Affairs

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POST DATE 9/16/2017
END DATE 11/5/2018

Regeneron Pharmaceuticals, Inc. Rensselaer, NY

Rensselaer, NY
AJE Ref #
Job Classification
Full Time
Job Type
Company Ref #
Entry Level (0 - 2 years)


img src="" p 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. br / br / strong Summary: /strong Maintain active engagement with emerging and current regulatory trends in the industry and act in a consultative capacity to the Industrial Operations and Product Supply division 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 BLAs/MAAs and track regulatory commitments. br / br / strong Essential Duties and Responsibilities /strong include, but are not limited to, the following: /p ul dir="ltr" li Manage timelines in cooperation with project management, SMEs and Regulatory Operations (Reg Ops) to ensure on-time regulatory submissions. /li li Assist with the planning, scientific writing and perform critical reviews of pre-INDs, INDs, IMPDs, BLAs, MAAs, annual reports, DSUR, amendments, supplements to ensure a high quality regulatory submission and approval /li li Ensure that all regulatory submissions are of highest regulatory standards. /li li Coordinate and manage regulatory inspections, as needed, at the Rensselaer site or at other sites if the inspection relates to regulatory CMC issues. /li li 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 CMC related changes are reported to competent authorities in accordance with regulatory requirements. /li li Support establishing, managing and maintaining a knowledge base of current and emerging regulatory requirements and guidelines in the CMC field. /li li Assist in tracking of CMC regulatory commitments for INDs/IMPDs, CTAs, and BLAs/MAAs. /li li Participate, as needed, in planning, organizing and managing the CMC component of pre-IND, pre-BLA and other Type C meetings with the FDA. /li li Support IOPS by providing CMC related guidances so that their short-term and long-term goals are achieved on time and with highest quality. /li li Participate in CMC project team meetings and provide current regulatory requirements that pertain to stability studies and analytical characterization tests. /li /ul