- 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 ... CMC Development supporting the two functional areas. The Associate / Manager is responsible for CMC regulatory operations, CMC change management, and… more
- Lilly (Philadelphia, PA)
- …creative solutions to support communities through philanthropy and volunteerism. **Position Overview:** The Manager - CMC Regulatory is responsible for the ... preparation and delivery of high-quality CMC regulatory submissions. This position supports Lilly/Avid diagnostic radiopharmaceutical marketed products globally.… more
- Otsuka America Pharmaceutical Inc. (Columbus, OH)
- Provide CMC regulatory strategy input and expertise in the area of investigational, new and marketed biologic and small molecule drug products to assigned ... drug manufacturing processes, GMP and related issues. + Knowledge of CMC regulatory requirements for biologics and small molecules during development and… more
- Orchard Therapeutics (Boston, MA)
- …business priorities. This role represents a unique opportunity to contribute to Regulatory CMC activities supporting maintenance and development of Orchard's ... products in clinical development: . Participate in definition and implementation of Regulatory CMC strategy for assigned program(s). . Collaborate with Technical… 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 ... internal and external partners to deliver products to patients. Prepares CMC regulatory strategies that enable first pass approvals. Develops and manages content… 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
- Gilead Sciences, Inc. (Foster City, CA)
- …Join Gilead and help create possible, together. **Job Description** **Responsibilities** + The Regulatory Affairs CMC Senior Manager at Gilead is responsible ... for providing strategic direction, tactical support, and technical expertise for CMC regulatory activities and related regulatory initiatives. + Responsible… more
- Vera Therapeutics (Brisbane, CA)
- …Development in project teams. * Prepare, review, or edit cGMP batch records, CMC regulatory and quality documents. Qualifications: * PhD/MS in relevant life ... Title: Senior Manager , Early-Stage Biologics Development, CMC Location:...addition, the role requires authoring, reviewing, and editing of CMC related regulatory submissions and associated quality… more
- AbbVie (North Chicago, IL)
- …documents of high scientific and technical quality that are compliant with global regulatory requirements. Partners with CMC teams during the development of ... (https://www.tiktok.com/@abbvie) . Job Description This position participates in global regulatory dossier preparation activities by gathering information from internal… more
- The US Pharmacopeial Convention (USP) (Rockville, MD)
- …an inclusive and collaborative work environment. **Brief Job Overview** The **Senior Manager , Chemical Manufacturing and Controls ( CMC ) Technical Advisor** is a ... to promote engaged, collaborative, and results-driven work environments. **The Senior Manager , Chemical Manufacturing and Controls ( CMC ) Technical Advisor** has… 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)
- …to Cardinal Health_** The _Scientist I, Chemistry, Manufacturing, and Control ( CMC )_ ensures efficient and quality production of product submission dossiers for ... Cardinal Health's Regulatory Science clients. Working remotely under the supervision of the CMC Supervisor, the Scientist I builds and formats Common Technical… more
- UTMB Health (New Boston, TX)
- CMC Medication Aide Student Trainee - Telford Unit **New Boston, Texas, United States** **New** Allied Health UTMB Health Requisition # 2502124 The mission of ... + Assists with patient activities and care as assigned by the nurse manager /designee as indicated by the patient's plan of care. Maintains patient care areas… 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...understanding of ICH guidelines, Data integrity requirements and other regulatory requirements a plus. + Good written and oral… 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 ... seeking a dynamic, highly motivated, and experienced individual for the position of **Senior Manager , Regulatory Affairs** . The Senior Manager is part of… 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
- 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 About Us: Vera Therapeutics (Nasdaq: VERA), is a late clinical-stage biotechnology… 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 ... and within established budgets + Work collaboratively with members of the global regulatory team (GRL, Clinical Transparency, Medical Writing, GRA- CMC , etc.) to… more
- Amgen (Washington, DC)
- …or analytical development + Experience in drug delivery device or diagnostics device regulatory submission process + Regulatory CMC specific knowledge and ... 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
- Otsuka America Pharmaceutical Inc. (Columbus, OH)
- …business units as needed. - Works collaboratively with members of the global regulatory team (GRL, regional leads, CMC -RA, labeling, medical writing, ... **Position Summary** Provides critical support in developing global regulatory strategy, planning and execution of global investigational and marketed prescription… more
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