- Merck & Co. (Rahway, NJ)
- …arms within the business.-- - - Working independently, the Protocol Clinical Supplies Project Manager ( Protocol CSPM) designs strategic and operational plans ... process & connectivity between functions supporting pipeline (ie clinical development, CMC , supply chain, & human health), and balancing needs of patients… more
- Merck & Co. (Rahway, NJ)
- …the operational/executional arms within the business.-- - - The Program Clinical Supplies Project Manager (Program CSPM) serves as the primary program-level GCS ... process & connectivity between functions supporting pipeline (ie clinical development, CMC , supply chain, & human health), and balancing needs of patients… more
- Aequor (Thousand Oaks, CA)
- …years of experience would be ideal Lifecycle management Product labeling and CMC changes Demand management and planning Forecasting and trending Supply planning Nice ... and work with region's cross functional team as needed (Commercial, Finance, Regulatory Affairs, Quality) to develop compliant product supply strategy for the… more
- Lilly (Philadelphia, PA)
- …to make life better for people around the world. Responsibilities: The Associate / Manager , CMC Regulatory and IMP Manufacturing Operations is a hybrid ... Development supporting the two functional areas. The Associate / Manager is responsible for CMC regulatory...of 1 year of experience in pharmaceutical development, manufacturing, CMC regulatory , project management, and/or… more
- Otsuka America Pharmaceutical Inc. (Columbus, OH)
- Provide CMC regulatory strategy input and expertise...and inquiries. + Represents CMC RA in project team meetings and provides regulatory guidance ... technology, drug manufacturing processes, GMP and related issues. + Knowledge of CMC regulatory requirements for biologics and small molecules during development… more
- Amgen (New Albany, OH)
- … Site Team is responsible for input to the development and implementation of CMC regulatory strategies and activities for products manufactured at or planned for ... manufacturing, testing (QC/QA or clinical), or distribution in Pharmaceutical/Biotech industry + Regulatory CMC experience + Ability to develop solutions to… more
- AbbVie (North Chicago, IL)
- …Tik Tok (https://www.tiktok.com/@abbvie) . Job Description The Senior Manager Regulatory Affairs, Chemistry, Manufacturing and Controls ( CMC ) works with ... department. Participates in initiatives internal to RA CMC . Represents CMC regulatory affairs on project initiatives with other functional areas to… more
- Vera Therapeutics (Brisbane, CA)
- …and review relevant sections for regulatory submissions. * Participate and represent CMC Process Development in project teams. * Prepare, review, or edit ... Title: Senior Manager , Early-Stage Biologics Development, CMC Location:...cGMP batch records, CMC regulatory and quality documents. Qualifications: *… more
- Bristol Myers Squibb (Indianapolis, IN)
- …API manufacturing processes. . Author technical reports and source documents to support regulatory filing. . Author CMC sections for IND/NDA for FDA submissions, ... to be the global leader in radiopharmaceuticals. **Position Summary** The Manager (Sr. Scientist), Radiopharmaceuticals will be responsible for advancing scientific… more
- Cardinal Health (Columbus, OH)
- …systems and contributes to reports and presentations for clients. May serve as a project manager for smaller projects and ensure that team members achieve ... hands-on guidance of experienced Scientists, learns variety of internal, client, and regulatory systems and develop authoring and project management skills… more
- LGC Group (Petaluma, CA)
- …and stability testing of oligonucleotide API and raw materials in compliance with regulatory standards to ensure the safety and consistency of products. We have an ... Reviewer will work under the supervision of the QC Manager and collaborate directly with QC scientists to achieve...of raw materials and investigation as required to maintain project timelines. Qualifications + Bachelor's degree in Chemistry or… more
- Sumitomo Pharma (Columbus, OH)
- … Team (GRT) + Supports the global regulatory lead (GRL) and the CMC regulatory lead in the formulation of regulatory strategy, and interactions ... motivated, and experienced individual for the position of **Senior Manager , Regulatory Affairs** . The Senior ...information requests. This position represents GRA on less complex project related meetings and provides regulatory input… more
- Fresenius Medical Center (Knoxville, TN)
- …to comply with regulatory requirements + Organization of submission-readiness of regulatory documentation (eg, CMC relevant parts) + Organize and support ... The internal Job Title is called **Global Product Center Manager (m/f/d) - Sterile Fluids (Medicinal Products).** **Main Responsibilities:** + Support as … more
- AbbVie (North Chicago, IL)
- …and Tik Tok (https://www.tiktok.com/@abbvie) . Job Description AbbVie is seeking an Associate Project Manager to drive the execution and oversight of projects ... to enable the early-stage pipeline. This will be in collaboration with our CMC team, CMC Product Development Director, and Delivery System Senior Leadership.… more
- Vera Therapeutics (Brisbane, CA)
- …development programs. The Senior Manager will support both Clinical Regulatory and CMC activities. Responsibilities: * Proactively manage regulatory ... Title: Senior Manager , Clinical Regulatory Location: Brisbane, California...content that meets current regional requirements * Represent clinical Regulatory Affairs on cross-functional project teams *… more
- Otsuka America Pharmaceutical Inc. (Columbus, OH)
- …of the associated regulatory challenges to the GRL, global regulatory team, assigned project teams, and internal/external functional business units ... associated regulatory challenges to the GRL, global regulatory team, assigned project teams, and internal/external...needed. - Works collaboratively with members of the global regulatory team (GRL, regional leads, CMC -RA, labeling,… more
- Otsuka America Pharmaceutical Inc. (Columbus, OH)
- The Sr. Manager , CTA Regulatory Strategy is responsible for providing critical support in developing global regulatory strategy, planning, and execution of ... budgets + Work collaboratively with members of the global regulatory team (GRL, Clinical Transparency, Medical Writing, GRA- CMC...to regulatory agencies and compliance with electronic regulatory standards + Oversees project team members… more
- Amgen (Washington, DC)
- …or diagnostics device regulatory submission process + Regulatory CMC specific knowledge and experience + Mature project management and organizational ... the professional you are meant to be in this meaningful role. ** Regulatory Affairs Manager - Combination Products** **What you will do** Let's do this. Let's… more
- Merck (Rahway, NJ)
- …arms within the business. Working independently, the Protocol Clinical Supplies Project Manager (Protocol CSPM) designs strategic and operational plans ... process & connectivity between functions supporting pipeline (ie clinical development, CMC , supply chain, & human health), and balancing needs of patients… more
- Merck (Rahway, NJ)
- …and the operational/executional arms within the business. The Program Clinical Supplies Project Manager (Program CSPM) serves as the primary program-level GCS ... process & connectivity between functions supporting pipeline (ie clinical development, CMC , supply chain, & human health), and balancing needs of patients… more
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