- 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. (Albany, NY)
- 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
- AbbVie (North Chicago, IL)
- …and Tik Tok (https://www.tiktok.com/@abbvie) . Job Description The Manager , Regulatory Affairs for Chemistry Manufacturing & Controls ( CMC ) works with ... policies and procedures within the regulatory affairs department under supervision of manager . Participates in initiatives internal to RA CMC . This is an… 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 (Hartford, CT)
- …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 (Frankfort, KY)
- … 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
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