- AbbVie (North Chicago, IL)
- …(https://www.tiktok.com/@abbvie) . Job Description The Associate Director Regulatory Affairs, Chemistry, Manufacturing and Controls ( CMC ) works with ... CMC development of peptides and sterile injectables. This individual prepares CMC regulatory strategies that enable first pass approvals. Develops and… 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
- Kelly Services (South San Francisco, CA)
- Kelly(R) Science & Clinical is seeking an Associate Director of CMC Project Management for a one-year contract opportunity with a leading biopharmaceutical ... industries. **Workplace:** Hybrid, onsite in South San Francisco, CA **Position Title:** Associate Director , CMC Project Management **Position Type:**… more
- Boehringer Ingelheim (Ridgefield, CT)
- …currently seeking an Associate Director or Senior Associate Director to join our External Alternative CMC Development (EACD) department located at ... activities within the project(s), in support of CMC development within EACD. The Associate Director /Senior Associate Director of EACD for drug… more
- Lilly (Philadelphia, PA)
- …new medicines, and advance care for patients with unmet needs. **Position Overview:** The Associate Director , CMC Development will be responsible for the ... Process Development, Analytical Sciences, Manufacturing, Quality, Supply Chain, R&D, Finance, and Regulatory to ensure delivery of CMC milestones for priority… more
- AbbVie (North Chicago, IL)
- …external third parties. The primary function is to ensure consistent preparation of CMC regulatory submission documents of high scientific and technical quality ... strong negotiating, influencing, and leadership skills. + Manages completion of CMC regulatory submission documentation for multiple projects of moderate… more
- AbbVie (Boston, MA)
- …and Tik Tok (https://www.tiktok.com/@abbvie) . Job Description Purpose: The Associate Director will be fully accountable for providing CMC leadership to both ... biologics manufacturing, process development and process characterization to management and to regulatory agencies. + Prepare and review regulatory briefings and… more
- Takeda Pharmaceuticals (Boston, MA)
- …is true to the best of my knowledge. **Job Description** **About the role:** As a CMC Lead, Small Molecules ( Associate Director ), you will be responsible for ... to the world. **How you will contribute:** + Provide strong direction to CMC Leads to drive effective life cycle management for Takeda's commercial small molecule… 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
- Organon & Co. (Plymouth Meeting, PA)
- …Position** Reporting to the Director or Executive Director in Organon Regulatory CMC , the Associate Principal Scientist is responsible for developing ... assigned products across the product lifecycle. + Identify, communicate and escalate potential regulatory issues to Organon Regulatory CMC management, as… more
- Amneal Pharmaceuticals (Piscataway, NJ)
- …and company goals and objectives. Essential Functions: + Develop and Execute Global Regulatory Strategies: Formulate and lead global CMC and clinical ... compliance with FDA, EMA, and Health Canada regulations. Assess regulatory impact of changes in CMC procedures...regulations. Assess regulatory impact of changes in CMC procedures and oversee internal regulatory guidance… more
- Otsuka America Pharmaceutical Inc. (Salem, OR)
- ** Associate Director , Small Molecule Analytical Development** + Lead and oversee phase appropriate method development and optimization for drug substance and ... drug substance and drug product ensuring compliance with relevant ICH and regulatory guidelines + Develop and implement stability study protocols and timelines,… more
- Takeda Pharmaceuticals (Boston, MA)
- …application is true to the best of my knowledge. **Job Description** **Title: Associate Director -Process Engineer SM API Process Sci** **Location: Cambridge, MA ... (Hybrid)** **About the role:** As an Associate Director -Process Engineer SM API Process Sci,...o Other key functional groups such as Global Quality, Regulatory CMC etc. **Leadership** + Provide vision… more
- Organon & Co. (Plymouth Meeting, PA)
- …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
- BeOne Medicines (Emeryville, CA)
- …to lead our Research, Supply Production and Financial Analytics Initiatives. The Associate Director Research, Supply Production and Financial Analytics, Data ... tools for early discovery and translational research, supply readiness, CMC , cross-functional resource utilization, vendor performance and cost scenario modeling… more
- Sanofi Group (Framingham, MA)
- **Job Title:** GRA Device Lead ( Associate Director ) **Location** : Morristown, NJ/ Cambridge, MA/ Framingham, MA **About the Job** Are you ready to shape the ... 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
- Sanofi Group (Morristown, NJ)
- **Job Title:** GRA Device Lead ( Associate Director ) **Location:** Cambridge, MA/ Morristown, NJ **About the Job** Are you ready to shape the future of medicine? ... 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
- University of Southern California (Los Angeles, CA)
- cGMP Associate Director , Process DevelopmentApply (https://usc.wd5.myworkdayjobs.com/ExternalUSCCareers/job/Los-Angeles-CA Health-Sciences-Campus/cGMP- ... cell and gene therapies and other biological products for internal/external users. The Associate Director of Process Development (cGMP) is responsible for all… more
- Merck (West Point, PA)
- **Job Description** The Associate Director , Engineering, Packaging Commercialization will lead packaging development for new products including parenteral ... prior experience developing and commercializing new products on cross-functional teams. The Associate Director will be accountable for the definition and… more