- Boehringer Ingelheim (Ridgefield, CT)
- …seeking a talented and innovative Data Science co-op to join our CMC Regulatory Affairs department located at our Ridgefield facility. As an co-op, you ... will utilize your data science background to optimize ...+ _Evaluate federal state regulations to ensure reports meet regulatory needs_ + _Optimize CMC databases and… more
- Merck (West Point, PA)
- …development through commercialization, with practical insight into how these operations generate CMC regulatory content + Understanding of CMC operations, ... enabled by a dedicated application designed to create a frictionless flow of data from source systems to regulatory documentation. Under the guidance of… more
- Bristol Myers Squibb (Indianapolis, IN)
- …to the Head of Regulatory Affairs and will oversee and/or manage CMC regulatory functions within the RayzeBio manufacturing facility located in Indianapolis. ... submissions + Lead the development and execution of global CMC regulatory strategies for activities conducted at...DMF, NDA and MAA applications. + Understanding of phase-appropriate data requirements for regulatory filings + Experience… more
- Organon & Co. (Jersey City, NJ)
- …assigned products across the product lifecycle + Identify, communicate and escalate potential regulatory issues to Organon Regulatory CMC management, as ... project timelines. **Preferred Experience and Skills** A candidate with experience in Regulatory CMC in clinical development, initial marketing application and… more
- Sanofi Group (Morristown, NJ)
- …was possible. Ready to get started? **Main Responsibilities:** + Develop global regulatory CMC strategies and risk assessments for development projects and/or ... that impact the company + Identify, communicate, and manage resolution to routine/complex regulatory CMC issues. Articulate the implication of issue to project… more
- Takeda Pharmaceuticals (Cambridge, MA)
- … types. **POSITION ACCOUNTABILITIES:** + Contribute to and/or serve as lead representing data science function on project teams in support of nonclinical studies ... that are statistical in nature. + Increase the external recognition of Takeda's data science work by participating in conferences, publishing work and developing… more
- Sanofi Group (Framingham, MA)
- …Leader leads a cross-functional CMC team with representatives from CMC Development, Manufacturing and Supply, Quality, Dossiers, Regulatory , Demand and ... company with one purpose: to chase the miracles of science to improve people's lives. We're also a company... contributions to pre-clinical, clinical and validation (DS/DP), and CMC elements for regulatory submissions and consultations.… more
- Boehringer Ingelheim (Duluth, GA)
- …sciences, including small molecule and biologic drug development, analytical chemistry, formulation science , and regulatory CMC strategy. + Adept at ... with corporate goals. + Defines, plans, and oversees the development of high-quality CMC regulatory submissions, with a focus on securing timely approvals from… more
- Merck (North Wales, PA)
- …products that improve human health and business. Under GPAM, the CMC Integrated Project Management (CIPM) organization supports Development and Commercialization ... Teams (DCTs) responsible for building and executing CMC development plans. Under the guidance of the CIPM...Experience and Skills:** + Advanced scientific degree (Master of Science (MS), Master of Business Administration (MBA), PharmD, Ph.D.)… more
- Sanofi Group (Framingham, MA)
- …digital technologies to build our next generation of data centralization and data consumption platforms. + Paperless CMC labs with end-to-end automated ... Digitized intra- & inter-laboratory workflows enable dataflows across all CMC and ensure data accessibility and integrity...company with one purpose: to chase the miracles of science to improve people's lives. We're also a company… more