- University of Pennsylvania (Philadelphia, PA)
- …Microsoft Teams, Zoom, Webex, etc. Knowledge and/or experience working with web-based e- regulatory document management systems such as eFlorence, Veeva Systems ... programs and resources, and much more. Posted Job Title Associate Director, Regulatory Job Profile Title Associate Director, Clinical Research Regulatory Job… more
- University of Pennsylvania (Philadelphia, PA)
- …Teams, Zoom, WebEx, BlueJeans etc. Knowledge and/or experience working with web-based e- regulatory document management systems such as eFlorence, Veeva Systems ... document tools, as well as, to provide direct regulatory /compliance guidance and facilitate investigator initiated trials and investigator-initiated multi-site… more
- University of Pennsylvania (Philadelphia, PA)
- …Zoom, WebEx, etc. Knowledge and/or experience publishing and working with web-based e- regulatory document management systems such as Veeva Systems products, etc. ... programs and resources, and much more. Posted Job Title Regulatory Specialist C Job Profile Title Clinical Research ...Regulatory Specialist C Job Profile Title Clinical Research Regulatory Specialist C Job Description Summary Regulatory … more
- Oracle (Harrisburg, PA)
- …Translate complex distributed system architecture (cloud-native, multi-region) into clear regulatory documentation. + Document engineering workflows across ... is entering a high-impact phase of **MDR (Medical Device Regulation)** readiness and ** regulatory transformation** . Over the next year, HDI must execute a large… more
- Sumitomo Pharma (Harrisburg, PA)
- … strategies and the ability to contribute to the development and writing of a regulatory strategy document + Ability to make complex decisions and willingness to ... highly motivated, and experienced individual for the position of **Associate Director, Regulatory Affairs (Oncology).** The Associate Director is part of the Global … more
- J&J Family of Companies (Spring House, PA)
- …of generative Artificial Intelligence (AI) writing and Quality Control (QC) tools for regulatory document generation. + Collaborate with Global Document ... and Translational Safety (PSTS) organization, will prepare and review regulatory submission documents that summarize toxicology, safety pharmacology, drug… more
- Otsuka America Pharmaceutical Inc. (Harrisburg, PA)
- …systems needed for the function including and not limited to CREDO ( document management), PRISM ( regulatory information management system), Global Trackwise, ... **Job Summary** The Chemistry, Manufacturing and Controls (CMC) Global Regulatory Affairs (GRA) professional is responsible for developing and executing global … more
- Sumitomo Pharma (Harrisburg, PA)
- … regulatory affairs activities; provide relevant input to Leadership + Oversee the regulatory activities at CROs, providing document review in order to ensure ... highly motivated, and experienced leader for the position of **Vice President, Regulatory Affairs Oncology** . The candidate must be deeply experienced in Oncology.… more
- Vanguard (Malvern, PA)
- …of new compliance standards. + Execute advisory and monitoring activities to assess regulatory posture, document , track, and drive the resolution of compliance ... ideal candidate is a proactive advisor who can integrate regulatory AI compliance considerations into the entire AI system...considerations into the entire AI system lifecycle - ensuring regulatory alignment and ethical standards in AI use cases.… more
- Oracle (Harrisburg, PA)
- …remedy risks and deficiencies. + Coordinates the preparation of and may prepare document packages for regulatory submissions from all areas of company as ... of conformance to, the requirements of government regulations and/or regulatory agencies. **Responsibilities** + Performs evaluation of internal operations,… more