- Astellas (Westborough, MA)
- …Research Associate II, Analytical Development Senior Project Manager, Technical Operations Senior CMC Regulatory Affairs Manager, Cell/Gene Therapy Manager ... Supervisor, Manufacturing (2nd Shift) Facility Engineering Maintenance Scheduler Manufacturing Specialist Manufacturing Supervisor QC Analyst I, Analytical QC Analyst...CMC Regulatory Affairs , Gene Therapy Associate Director CMC … more
- Bausch + Lomb (Bridgewater, NJ)
- …leading the advancement of eye health in the future. **Job Objectives** The Regulatory Affairs (RA) CMC Sr. Specialist manages all regulatory CMC ... The Senior Specialist is responsible for the regulatory CMC strategy of all submissions and...interdisciplinary project teams and to appropriate management level in Regulatory Affairs , R&D, TechOps and Supply Chain… more
- Mallinckrodt Pharmaceuticals (St. Louis, MO)
- Job Title Senior Regulatory Affairs Product Specialist Requisition JR000013781 Senior Regulatory Affairs Product Specialist (Open) Location ... Additional Locations St. Louis, MO Job Description The Senior Regulatory Affairs Product Specialist (RAPS)... affairs department. + Ability to interpret Regulatory Authority policies and CMC guidance and… more
- Bausch + Lomb (Bridgewater, NJ)
- …the advancement of eye health in the future. **Objectives/Purpose of Job:** + The Regulatory Affairs Senior Specialist handles US regulatory development ... Regulatory Authorities for assigned products. + Liaise with country-specific regulatory affairs personnel for international submissions and registrations. +… more
- ConvaTec (Lexington, MA)
- Product Regulatory Affairs work includes: *Directing submission development of product registration, progress reports, supplements, amendments, and/or periodic ... ( CMC ) *Ensuring pre-clinical and clinical trial designs meet regulatory requirements *Ensuring rapid and timely approval of new drugs, biologics/biotechnology… more
- Sanofi Group (Bridgewater, NJ)
- …of the Global Regulatory Team (GRT), and strategic partner to the Global Regulatory Lead (GRL), the Regulatory Specialist leverages their regulatory ... pharmaceutical/biotechnology industry experience, including at least 4 years of relevant Regulatory Affairs experience (regionally and/or global) especially in… more
- Rush University Medical Center (Chicago, IL)
- …and coding. Certifications may include Certified Professional Coder (CPC), Certified Coding Specialist (CCS) and Certified Medical Coder ( CMC ), and any other ... communicates with Revenue Cycle colleagues, study teams, patients, Office of Research Affairs , IRB, RUMC Compliance, and all partners in the Research Continuum. *… more