- Merck & Co. (North Wales, PA)
- …The Principal Scientist / Director responsibilities include but are not limited to:Serve as a Regulatory CMC Project Lead and provide CMC Regulatory ... measures. Lead the development, communication, and review of the CMC Regulatory Strategy Document for projects of increasing complexity. Lead development… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …as well as other research areas centered around rare diseases and immune disorders. Summary CMC Lead is responsible for supporting the overall CMC strategies ... and the respective development stage of the project. The CMC Lead will support the Sr. ...preferred- 1 or More Years Extensive knowledge of global CMC regulatory requirement and preferably NDA or… 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 ... & overall first level of project guidance. Relationships Reports into Director, CMC Program Development. Essential Functions Project Management Lead programs, or… more
- BioAgilytix (Durham, NC)
- …life-saving therapeutics to the patients who need them.Essential ResponsibilitiesServe as lead scientist on assay development projectsServe as lead scientist ... in a supervisor role and leading teams Knowledge and application of regulatory guidance to experimental planning and design Experience working in GxP environments… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …and China, and indirect accountability for JP representatives. As part of leading Regulatory Intelligence, this role will lead the development and implementation ... biologics and Oncology, incl. coordinating Reg Intelligence & Policy activities with the Regulatory - CMC function and corporate affairs as needed. In the short… 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 ... The Technology Management (mAb, Drug Substance, Drug Product, or New Modality) Lead is responsible for the management of technology transfer of the manufacturing… 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
- Insmed Incorporated (Bridgewater, NJ)
- …discipline. DABT/DACVP certification preferred.Minimum of 15 years of experience as a regulatory toxicologist (study director/monitor and/or project lead ) in the ... oversee safety pharmacology and toxicology studies, author nonclinical sections in regulatory submission documents, and address regulatory inquiries. This… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …generation, design and leadership of clinical development plans, and addressing all regulatory , drug and patient safety, data, CMC , IP, patient selection, ... In this key role, the candidate will have to lead a complex, global team in charge of a...competitive, asset strategy and execution to ultimately achieve global regulatory filings and ensure wide access of the compound.… 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
- Insmed Incorporated (Bridgewater, NJ)
- …discipline. DABT/DACVP certification preferred.Minimum of 10 years of experience as a regulatory toxicologist (study director/monitor and/or project lead ) in the ... discipline. DABT/DACVP certification preferred.Minimum of 10 years of experience as a regulatory toxicologist (study director/monitor and/or project lead ) in the… 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
- 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
- Merck & Co. (Rahway, NJ)
- …across the organizations (Research Division/Manufacturing Division), such as Analytical, Quality, Regulatory CMC , and technical functions, to ensure timebound ... chemistry, biopharmaceutics, material science, process development, and/or engineering and regulatory science.Proven ability to lead program development teams… more
- Aequor (Seattle, WA)
- …supporting commercial vector manufacturing processes. This person will collaborate across all CMC functional areas to insure project advancement, rapid and best in ... team to identify opportunities for process improvements, make formal recommendations. Lead identification and implementation of new technologies and procedures from… 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 ... process, and succinctly present findings and recommendations to senior management Lead critical aspects of the technology partnership process: identify promising… 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 ... Position Summary The Director of Project Management will lead a team of project management professionals ensure projects are executed effectively and efficiently… more
- FUJIFILM Holdings America Corporation (Boston, MA)
- …calls with C-level and senior leaders at client accounts; prepare and lead presentations and facilitate site visitsWork closely and collaboratively with Project ... Management, Quality, Technical Operations, R&D and other relevant groups to lead generation and presentation of proposalsWork with customers as well as internal… more
- Editas Medicine (Cambridge, MA)
- …of regulatory success, and proposing risk mitigation measures. + Serve as a Regulatory CMC lead on relevant cross-functional or functional teams to ... EMA/FDA/ICH/WHO/Global regulations and regulatory guidance and guidelines. + Lead CMC related interactions with the health authorities including but not… more
- Merck (North Wales, PA)
- …Principal Scientist / Director responsibilities include but are not limited to:** + Serve as a Regulatory CMC Project Lead and provide CMC Regulatory ... measures. + Lead the development, communication, and review of the CMC Regulatory Strategy Document for projects of increasing complexity. + Lead … more
