- Merck & Co. (Rahway, NJ)
- … CMC (Chemistry, Manufacturing & Controls), you will report to the Director of Device Regulatory Affairs for Autoinjector Development Programs. ... medical device or combination product research, development and/or manufacturingExperience in CMC regulatory (IND, CTA, BLA, MAA) with a drug-device… more
- Regeneron Pharmaceuticals (Tarrytown, NY)
- …for assigned cell and gene therapy portfolios. This role includes overseeing regulatory affairs staff, various outside contractors, supporting project teams and ... typical day might include:** + Direct activities of assigned Regulatory Affairs team with emphasis on global...policies + Provide and drive strategic and operational global CMC regulatory direction and documentation for portfolio… more
- Merck (Rahway, NJ)
- … CMC (Chemistry, Manufacturing & Controls), you will report to the Director of Device Regulatory Affairs for Autoinjector Development Programs. ... control activities and documentation reviews + Provide evaluations of regulatory state of affairs of any devices...combination product research, development and/or manufacturing + Experience in CMC regulatory (IND, CTA, BLA, MAA) with… more
- Mitsubishi Chemical Group (Jersey City, NJ)
- …researching on real-world evidence, and creating hope for all facing illness. The Director , Regulatory Affairs provides strategic global regulatory ... in the rare disease space. In this role, the Director defines and implements regulatory strategies; works...requests, and briefing documents. + Acts as liaison between Regulatory Affairs and other functional areas, including… more
- Teva Pharmaceuticals (Parsippany, NJ)
- …independently, as needed + Partners cross-functionally with departments such as Regulatory Affairs , Toxicology, CMC /Formulations, Biostatistics, Legal, ... documents (ie protocols, Investigator's Brochures, clinical study reports, summaries for regulatory submissions). The Senior Director , Clinical Development will… more
