- Organon & Co. (Jersey City, NJ)
- …Reporting to the Director or Executive Director in Organon Regulatory Chemistry, Manufacturing and Controls ( CMC ), the Associate Principal Scientist ... assigned products across the product lifecycle. + Identify, communicate and escalate potential regulatory issues to Organon Regulatory CMC management, as… more
- Formation Bio (New York, NY)
- …to patients faster and more efficiently.About the PositionFormation Bio is seeking an Associate Director , Program Management - Asset Diligence & Integration to ... from initial evaluation to pre-close. Coordinate cross-functional workstreams (Clinical, CMC , Regulatory , Nonclinical, QA, Commercial, Finance, Legal/IP).… more
- Insmed Incorporated (NJ)
- …for the future of science, we're in. Are you?About the Role:We're looking for an Associate , Regulatory Operations on the Regulatory team to help us expand ... what's possible for patients with serious diseases. Reporting to the Executive Director , Regulatory Operations, you'll be responsible for the publishing,… more
- Organon & Co. (Jersey City, NJ)
- …INDs, briefing books and other regulatory documents, as applicable. The Associate Director , Biopharmaceutics will be the primary author for module 2.7.1 ... **Job Description** **The Position** The Associate Director , Biopharmaceutics will provide expert...to and/or review the nonclinical, early clinical development or CMC documentation to support regulatory or other… more
- Insmed Incorporated (NJ)
- …us expand what's possible for patients with serious diseases. Reporting to the Associate Director , Regulatory Affairs, Tactical Implementation, you'll have a ... activities across assigned programs and market. Under the guidance of the Associate Director , you will ensure high-quality, timely, and compliant preparation… more
- Lilly (Philadelphia, PA)
- …to make life better for people around the world. **Position Overview:** The Associate Director - CMC Regulatory will leverage CMC technical knowledge ... and regulatory science expertise to drive global regulatory CMC strategies for Lilly | Avid diagnostic radiopharmaceutical products. This includes the… more
- BeOne Medicines (San Mateo, CA)
- …assigned projects. The individual will provide support to cross-functional teams on CMC regulatory strategies and process optimizations on relevant topics. ... **Essential Functions of the job:** + Lead, develop and implement small molecule CMC regulatory strategies as well as authoring CTD CMC sections for the… more
- Atlantic Health System (Pompton Plains, NJ)
- …revision of procedures and documentation related to accreditation, adhering to all regulatory requirements for various authorities, including but not limited to CAP, ... medical laboratory technology/ medical or clinical laboratory science preferred + Associate 's degree in chemical, physical or biological science or medical… more
- Sumitomo Pharma (Lincoln, NE)
- …seeking a dynamic, highly motivated, and experienced individual for the position of ** Associate Director , Regulatory Affairs (Oncology).** The Associate ... Director is part of the Global Regulatory Affairs (GRA) team based in the US. He/She...the global regulatory lead (GRL) and the CMC regulatory lead in the formulation of… more
- Sanofi Group (Morristown, NJ)
- **Job title** : Global Regulatory Affairs Device Lead ( Associate Director ) **Location** : Morristown, NJ or Cambridge, MA or Framingham, MA **About the Job** ... critical in helping our teams accelerate progress. The Global Regulatory Affairs (GRA) Device team is a globally diverse...of products. The team is part of the GRA CMC & GRA Device Department within Global R&D. The… more
- AbbVie (Irvine, CA)
- …+ Author and review CMC analytical sections of BLA and other CMC regulatory packages. Develop strategies for addressing health authority inquiries. + Provide ... supports manufacturing, process transfer/optimization/characterization/validation, analytical method transfer/optimization/validation, product characterization, regulatory submission, and continuous improvement for late-stage and commercial… more
- AbbVie (North Chicago, IL)
- …automation systems strategy and roadmap in alignment with department objectives and SM CMC R&D strategies. . Develop and revise project plans and budgets, work with ... . Provide guidance, technical advice, planning, and project management within SM CMC and with outside functions, consultants, and vendors. Support to laboratory… more
- Takeda Pharmaceuticals (Boston, MA)
- …**Job Description** **Title: Process Engineer Small Molecules API Process Science ( Associate Director )** **Location: Cambridge, MA (Hybrid)** **About the role:** ... As a Process Engineer Small Molecules API Process Science ( Associate Director ), you will provide process engineering...+ Other key functional groups such as Global Quality, Regulatory CMC etc. **Leadership** + Provide vision… more
- Takeda Pharmaceuticals (Cambridge, MA)
- …true to the best of my knowledge. **Job Description** **About the role** As Associate Director , API Process Engineering, you will be Takeda's global expert for ... strategy), site leadership, Technical Services, Pharmaceutical Sciences, Global Quality, and Regulatory CMC . + Provide technical support to marketing… more
- Mallinckrodt Pharmaceuticals (Horsham, PA)
- Job Title Associate Director , Manufacturing Operations Requisition JR000015470 Associate Director , Manufacturing Operations (Open) Location Horsham, PA ... Additional Locations Job Description Summary Job Description The Associate Director , Manufacturing Operations will provide leadership and management of… more
- J&J Family of Companies (Spring House, PA)
- …America **Job Description:** **We are searching for the best talent for our Associate Director , Bioanalysis position located in Spring House, PA.** **About ... Discovery & Development & Sciences) organization at Johnson & Johnson is seeking an Associate Director to lead the ADA Validation & Sample Testing Group located… more
- J&J Family of Companies (Spring House, PA)
- …at https://www.jnj.com/innovative-medicine **We are searching for the best talent for an Associate Director , Submission Program Management Lead to be located in ... SPML will be a key partner to the Global Regulatory Leader (GRL), Compound Development Team Leader (CDTL) and...near critical path (eg, LPO, DBL, TLR/TLG, CSR, Non-Clinical, CMC ) into ISP. + Maintaining and communicating execution level… more
- Sanofi Group (Waltham, MA)
- **Job Title:** Associate Director , Genomic Medicine Purification Process Development **Location:** Waltham, MA Work Model: M-F onsite **About the Job** Are you ... our teams accelerate progress. The Genomic Medicine Unit (GMU) CMC group at Sanofi is dedicated to the establishment...Group located in Waltham, MA in the role of Associate Director . The GMU PPD group operates… more
- Takeda Pharmaceuticals (Thousand Oaks, CA)
- …true to the best of my knowledge. **Job Description** **About the role** As Associate Director , Drug Product Manufacturing Science & Technology, you will be ... effectively with local Technical Services, site leadership, Pharmaceutical Sciences, Global Quality, Regulatory CMC , and other key functions to align on… more
- Takeda Pharmaceuticals (Boston, MA)
- …DP/PKG** **Location: Cambridge, MA** **About the role:** As a Process Scientist ( Associate Director ) - Global Manufacturing Science GMSci Drug Product (DP), ... and the life cycle management of existing products. You will lead regulatory interactions, including the preparation of Chemistry, Manufacturing, and Controls (… more
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