- Spectraforce Technologies Inc (Bridgewater, NJ)
- Job title: CMC Regulatory Technical Writer II Location: Bridgewater, NJ, Hybrid Duration: 1 year SHIFT SCHEDULE 1st shift, 9-5 EST Mon-Fri Pay Rate starts: $47/ ... Microsoft Office (Word, Excel, PowerPoint) VEEVA experience is a plus Description: The CMC Regulatory Technical Writer II authors high quality Module 2 and 3 … more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …project development preferred- 1 or More Years Extensive knowledge of global CMC regulatory requirement and preferably NDA or BLA/MAA submission experiences ... areas centered around rare diseases and immune disorders. Summary CMC Lead is responsible for supporting the overall ...CMC Lead is responsible for supporting the overall CMC strategies within projects, and manage project teams. The… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …biologics and Oncology, incl. coordinating Reg Intelligence & Policy activities with the Regulatory - CMC function and corporate affairs as needed. In the short ... is compatible with DS' strategic objectivesWork with other DS functions (incl. Regulatory - CMC ) to coordinate Regulatory Intelligence activities and ensure… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …The Associate Director, RACMC Portfolio Products, will be responsible for regulatory CMC (Chemistry, Manufacturing, and Controls) activities of the ... be responsible for working on cross-functional teams, developing and executing post-approval Regulatory CMC strategies, reviewing CMC information and data,… more
- Lundbeck (Bothell, WA)
- …and represent the Potency team as needed Assist in the preparation of CMC regulatory submissions including authoring and/or review REQUIRED EDUCATION, EXPERIENCE ... Center of Excellence for Biologics within the global Lundbeck CMC organization. Since integrating into Lundbeck in October 2019,...to the position is a thorough understanding of the regulatory and industry standards that are required for potency… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …or New Modality) team.- Support the compilation and technical review of relevant CMC sections of regulatory submissions (INDs/IMPDs, NDAs, BLAs, etc.), responses ... (mAb, Drug Substance, Drug Product, or New Modality) manufacturing, evaluates CMC risks for appropriate escalation, recommends transition milestones and ensures a… more
- Eisai, Inc (Nutley, NJ)
- …areas Advanced understanding of the drug development plans, preclinical toxicology, toxicology, CMC , regulatory and other development requirements as they relate ... to efficient execution of the development plans. Advanced understanding of clinical trial management, including general understanding of all specialized support functions. Budget management Ability to effectively prioritize work and engage in creative problem… more
- Merck & Co. (Rahway, NJ)
- …as well as o ur Research & Development Division Process, Analytical and CMC Regulatory groups.Defines, assesses, and presents business analyses for potential ... transactions requiring manufacturing input.-Serves as the central point of contact between - our Manufacturing Division - and all internal Company business areas to ensure appropriate manufacturing input is effectively incorporated into the potential… more
- Aequor (NJ)
- …and Monitoring (GSMM), Project Management, Client Affiliates, Medical Affairs (MA), Regulatory , CMC , QA, Packaging Vendors, CRO's, IRT Organizations, and ... studies during phases 1-4. The individual must partner closely with clinical, regulatory , quality and production associates to ensure timely delivery of supplies to… more
- Aequor (New Brunswick, NJ)
- …regulation Very good experience on New Product Introduction Very good understanding on Regulatory CMC , US/EU/ROW submission requirement for stability Hand on ... protocols, and preparation, review and approval of stability reports and regulatory filings. Major Duties and Responsibilities: The Principal Scientist stability is… more
- Insmed Incorporated (Bridgewater, NJ)
- …and statistical process control fundamentals.Experience with providing technical authoring of CMC drug substance sections of regulatory filings and ... optimization, clinical/commercial manufacturing, process characterization and validation, and manufacturing CMC development strategy. Remote (only in corp. office for… more
- Novo Nordisk Inc. (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 Boulder Site is home to the specialized technical operations/ CMC team for oligonucleotides and RNAi therapeutics, continuing its...of phosphoramidites and other critical raw materials for RNAi CMC Boulder. In addition to ensuring the supply of… more
- Tris Pharma (Monmouth Junction, NJ)
- …This includes, but is not limited to: Research, Product Development, Clinical Development, Regulatory Affairs, CMC , New Products, Sales & Marketing, and Legal ... evaluation; provide input on deal terms and creation of relevant clinical, regulatory , and commercial scenarios Prepare clear and concise presentations across a… more
- Novo Nordisk Inc. (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
- Option Care Health (Columbus, OH)
- …and resolving problems.Go-to for troubleshooting issues and resolutions with CMC Patient Registration team members.Maintains updated knowledge of industry, ... regulatory and reimbursement issues and of payer requirements. Keeps AVA team abreast of key changes.Assists with roll out of new policies and procedures. Supervisory… more
- Novo Nordisk Inc. (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
- Piper Companies (Philadelphia, PA)
- …authoring and review workflows including SharePoint and Master Control responsibilities for regulatory affairs and CMC regulatory .. Complete administrative ... Piper Companies is currently looking for an experienced Sr. Regulatory Specialist (IND Submissions) in Philadelphia, Pennsylvania (PA) to work for an innovative and… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …as other research areas centered around rare diseases and immune disorders. Summary The Regulatory Data Manager will be a key member of the Global Regulatory ... to facilitate consistency and quality of data across key Daiichi Sankyo regulatory systems. This includes defining regulatory data standards, data quality… more
- Exela Pharma Sciences, LLC (Lenoir, NC)
- …understanding of Pharma or life sciences manufacturing processes, cGMP practices, regulatory health authority CMC requirementsExperience with federal subsidy ... programs and government regulationsStrong communication skills, with the ability to effectively collaborate and build relationships with stakeholders at all levelsA highly motivated self-starter, capable of hitting the ground running and excelling in a high… more
- Merck & Co. (North Wales, PA)
- …integrating strategic and tactical input from diverse disciplines (eg, clinical, regulatory , market access, manufacturing, CMC , commercial, and other areas) ... as applicable to the project.Building and maintaining project schedules and critical project information in enterprise project management systems and databases; using these as tools to integrate activities across key team members, proactively identify risks,… more
