- Lilly (San Diego, CA)
- …clinical studies that efficiently test therapeutic hypotheses + Collaborate with clinical pharmacology, biostatistics, regulatory affairs , operations, and ... Discovery, Translational Medicine, Clinical Pharmacology, Quantitative Systems Pharmacology, Clinical Operations, Regulatory Affairs , and Search and… more
- University of Pennsylvania (Philadelphia, PA)
- …organizations (CROs), and the FDA , as well as, organize and maintain all regulatory affairs documentation/files as required. The Regulatory Affairs ... documentation through the IRB, FDA and all applicable institutional regulatory review committees. In collaboration with clinical research teams and… more
- CSL Behring (Waltham, MA)
- …(PST) and/or related global R&D/commercial teams, plus leads the corresponding Global Regulatory Affairs Strategy Team (GRAST) ensuring connectivity, 'One GRA ... or EMA) and maintaining productive relationship and driving positive regulatory outcomes with both FDA & EMA...one key region (EU, US, Japan) *Experience working in Regulatory Affairs with agency interaction responsibility with… more
- University of Pennsylvania (Philadelphia, PA)
- …specimens and manage study data and regulatory files per GCP.Work with Regulatory Affairs Specialist to prepare for audits, review regulatory binders, ... continuing reviews, amendments, modifications, and adverse event reporting and all regulatory documentation with pharmaceutical companies and clinical research… more
- CSL Behring (King Of Prussia, PA)
- …successful regulatory outcomes.** **Effectively partner with assigned product/s Global Regulatory Affairs Strategy Team (GRAST) GRL plus other regional, ... and approval in one key region (EU, US, Japan)** **Experience working in Regulatory Affairs with agency interaction responsibility with at least 1 health… more
- CSL Behring (King Of Prussia, PA)
- …standards (ICH, EMA, FDA ). * **Cross-functional Collaboration** Liaise with GRAS, clinical , medical affairs , and quality assurance teams to ensure alignment ... experience in the life sciences industry, with exposure to regulatory affairs or a related function. *Strong...intelligence or policy work is beneficial. *Previous interaction with regulatory agencies such as FDA or EMA… more
- Charles River Laboratories (Wayne, PA)
- …one or more Charles River operations and serves as a member of the Regulatory Affairs and Compliance management team. Provides direction in implementing the ... applicable regulatory requirements. ⦁ Assume a key role in designated Regulatory Affairs and Compliance projects and programs. ⦁ Participate in Corporate… more
- J&J Family of Companies (Titusville, NJ)
- …quality monitoring & compliance, clinical supplies unit, TA strategy, regulatory affairs , data management, medical writing, biostatistics, global medical ... clinical team in responding to medical and compound-related issues + Working with Regulatory Affairs and global clinical operations to respond to… more
- AbbVie (North Chicago, IL)
- …Advise internal customers who may contribute to regulated communication on Regulatory / FDA issues including Public Affairs , Clinical Development, Legal, ... Tik Tok (https://www.tiktok.com/@abbvie) . Job Description The Senior Manager, RA Global Regulatory Strategy US and Canada is responsible for the development and… more
- Cedars-Sinai (Los Angeles, CA)
- …plan and coordinate strategies to improve existing standard operating procedures related to regulatory Affairs including drafting SOP's and/or job aids. + May ... generates reports, and maintains research files and documentation involving the regulatory requirements for the study/ clinical trial. Other duties include,… more