- Regeneron Pharmaceuticals (Rensselaer, NY)
- The CMC Regulatory Affairs Specialist **is responsible for** for a subset of programs at the IOPS facility. Evaluate proposed changes to IOPS documents and ... with regulatory requirements, as necessary. * Tracks and/or completes CMC regulatory commitments for INDs/IMPDs, CTAs, and BLAs/MAAs. * Provides CMC… more
- Regeneron Pharmaceuticals (Troy, NY)
- The CMC Product Quality Regulatory Communications team is hiring! This team is responsible for being the primary Quality representative for product deviation and ... with globalization of Regeneron-owned markets + Interacts with global regulatory authorities in support of the CMC ...following amounts of proven experience for each level: + Specialist : Requires 2+ years + Senior Specialist :… more
- ConvaTec (Lexington, MA)
- …working relationships within RA group as well as internal/external customers. ** Regulatory Affairs Specialist work includes:** Direct submission development of ... ( CMC );** Ensure pre-clinical and clinical trial designs meet regulatory requirements;** Ensure rapid, timely approval of new drugs, biologics/biotechnology… more
- Kedrion Biopharma, Inc. (Fort Lee, NJ)
- …and clinicians in hematology, immunology, neurology, and transfusion medicine. The **Sr. Specialist for Regulatory Affair** **s** is responsible for ... the US dossiers and the execution of lifecycle and regulatory compliance activities of the assigned licensed products in...FDA for the assigned products. + Thoroughly reviews the CMC dossier created by the GPOs to ensure it… more
- Bausch + Lomb (Bridgewater, NJ)
- …advancement of eye health in the future. **Objectives/Purpose of Job:** + The Regulatory Affairs Senior Specialist handles US regulatory development aspects ... for Over-the-Counter (OTC) or cosmetic products, as assigned. + Provides Regulatory guidance to support marketed OTC monograph/NDA or cosmetic products. + Manages… more
- Novo Nordisk (Boulder, CO)
- …new laboratory completed in 2021 to support analytical and process development, the CMC team works alongside Quality, Regulatory , Technical Operations and RNAi ... the Department The Boulder Site is home to the specialized technical operations/ CMC team for oligonucleotides and RNAi therapeutics, continuing its legacy as the… more
- Novo Nordisk (Boulder, CO)
- …new laboratory completed in 2021 to support analytical and process development, the CMC team works alongside Quality, Regulatory , Technical Operations and RNAi ... the Department The Boulder Site is home to the specialized technical operations/ CMC team for oligonucleotides and RNAi therapeutics, continuing its legacy as the… 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 ... expertise to contribute to the definition of the global regulatory strategy, to enable and drive the execution of...strategy in collaboration with non-US - non-EU regions / GRA- CMC / GRA-Devices. Attends HA meetings and collaborates with… more
- Regeneron Pharmaceuticals (East Greenbush, NY)
- …across the company, including Manufacturing, Process Sciences (PS), Quality Control (QC), CMC Regulatory Sciences, and Quality Assurance (QA) to provide ... Regeneron is currently looking for a Materials Sciences Specialist for Extractables and Leachables (E&L) in the...projects and deliverables to support pre and post marketing regulatory commitment deadlines, and development of new projects and… more
- Merck (Boston, MA)
- …partner organizations such as Clinical Sciences and Study Management (CSSM), Regulatory , Chemistry, Manufacturing and Controls ( CMC ), Pharmaceutical Sciences, ... and packaging activities as well as supply chain documentation to support critical CMC activities. + Responsible for authoring the Clinical Supplies section of the… more
- Bausch Health (Bridgewater, NJ)
- …of improving people's lives with our health care products. The Quality Specialist provides support for the business' product development portfolio and ensures ... to Quality-by-Design principles as well as compliance with relevant regulatory requirements and corporate standards. Experience: + Partner with cross-functional… more
- Merck (North Wales, PA)
- …integrating strategic and tactical input from diverse disciplines (eg, clinical, regulatory , market access, manufacturing, CMC , commercial, and other areas) ... & Development organization at our company. **Position Description/Summary** The Senior Specialist , Project Manager is a core member of Early Drug Development… more
- Insight Global (Rahway, NJ)
- …largest pharmaceutical clients is looking for someone to join their Global Regulatory Affairs organization and Regulatory Information Management team to support ... change management initiatives, including managing a suite of documentation that supports regulatory processes and transforming this documentation with the use of the… more
- Actalent (Foster City, CA)
- …variety of activities to ensure compliance with applicable quality objectives and regulatory requirements * Serves as QA Lead for clinical and commercial projects. ... data for in-process and finished products. * Reviews method validation-related data in CMC sections of NDA / global filings. * Responsible for maintaining current… more
- Merck (Elkton, VA)
- …Company, including Technical Operations, Operations, Quality, commercialization, process development, Regulatory - CMC , Supply Chain, and Value Chain. **Key ... products and processes and their effective integration with relevant regulatory /GMP requirements + Collaborate effectively, across functional boundaries, to align… more
- Magellan Health Services (Albuquerque, NM)
- …engagement. This position provides direct supervision to all Care Management Center ( CMC ) peer support specialists. + Provides guidance and support to staff through ... + Serves as a champion for recovery principles within CMC and being a resource to CMC ...mental health or substance use advocate. Certified CPRS/CPS/CPSS/CRPS/PRSS, Peer Specialist . Must obtain within one year of hire NCPS/NCPRSS/National… more
- LA Care Health Plan (Los Angeles, CA)
- …the recruitment process. Job Summary The Customer Solution Center Audit Readiness Specialist II is responsible for the execution, oversight, and monitoring of the ... guidelines and protocols to ensure readiness for all regulatory audits. This position will develop, with the assistance...Seniors and People with Disabilities (SPD) and Cal MediConnect ( CMC ) plus HIF for LA Care Medi-Cal Direct program… more
- State of Colorado (Canon City, CO)
- …Monthly Location Canon City, CO Job Type Full Time Job Number CAA CMC HP ID&A 2023 Department Department of Corrections Division Clinical and Correctional Services ... the State of Colorado as a Certified Addiction Technician (CAT), Certified Addiction Specialist (CAS), or a current, valid license from the State of Colorado… more
- The Arora Group (Twentynine Palms, CA)
- …Joint Commission, URAC, Case Management Society of America (CMSA), and other regulatory requirements. Apply medical care criteria (eg, InterQual). + Provide nursing ... Certification of Disability Management Specialists Commission: Certified Disability Management Specialist (CDMS) + Association of Rehabilitation Nurses: Certified Rehabilitation… more
- Catholic Health (Buffalo, NY)
- …records for the purpose of accurate reimbursement, research, and compliance with regulatory agency mandates. Diagnoses are coded through review of all available ... + Certification as an RHIA or RHIT. Certified Coding Specialist (CCS) is preferred. Would also consider an RHIA...a Certified Professional Coder (CPC) or Certified Medical Coder ( CMC ) with certification from the American Academy of Professional… more