- Amgen (Thousand Oaks, CA)
- …partners such as Drug Substance Technologies, Drug Product Technologies, Product Quality, Regulatory CMC , and Supply Chain. The successful candidate will ... method and validation and transfers + Contribute to global regulatory filings by authoring analytical CMC sections...to global regulatory filings by authoring analytical CMC sections and RTQs ensuring success of commercial approval… more
- Gilead Sciences, Inc. (Foster City, CA)
- …and Operations and partner closely with Technical Development leadership, IT, Manufacturing, CMC Regulatory and the broader Gilead digital ecosystem. **Key ... and implementations + Foster relationships with internal partners (eg, IT, CMC RA) and external vendors **Innovation, Change Leadership, and Continuous Improvement**… more
- AbbVie (North Chicago, IL)
- …supply chain for pipeline molecules and help prepare and defend CMC regulatory content. Antibody-oligonucleotide conjugates represent a transformative approach ... development stages. R&D Process Engineering also partners with Biologics CMC (Chemistry, Manufacturing, and Controls) Development and Aesthetics R&D functions… more
- Amgen (Thousand Oaks, CA)
- …and/or oligonucleotide development and commercial lifecycle maintenance, product stability programs, CMC regulatory filings, risk assessment, and Amgen Quality ... executive leadership, International Quality, Quality Control, Contract Manufacturing Quality, Regulatory , Process Development, Quality Assurance, and other functional areas… more
- J&J Family of Companies (Spring House, PA)
- …Therapeutic Area. Ensure strategies are aligned with portfolio objectives, regional regulatory requirements, CMC considerations, commercial goals, and market ... impact health for humanity. Learn more at https://www.jnj.com **Job Function:** Regulatory Affairs Group **Job Sub** **Function:** Regulatory Affairs **Job… more
- BD (Becton, Dickinson and Company) (Warwick, RI)
- …the regulatory requirements and support the proposed product claims. + Review CMC changes and determine regulatory reporting category in accordance with FDA ... **Job Description Summary** The Senior Regulatory Affairs (RA) Specialist within the BD Interventional...BD Interventional Surgical Devices Business unit will work on regulatory strategy and various regulatory activities for… more
- Boehringer Ingelheim (Duluth, GA)
- …or to improve collaboration. The stakeholders will vary from USA GI Region, USA CMC , Corporate Affairs or regulatory agencies. + In partnership with RA project ... Operations Excellence Partner is to partner with the USA Regulatory Affairs team in executing key strategic and operational...initiatives to achieve USA priorities for RA and USA CMC objectives. This role is directly responsible for improving… more
- Bristol Myers Squibb (San Diego, CA)
- …and mentor junior scientists and associates. + Documentation: Draft and review CMC sections for regulatory submissions, SOPs, and comprehensive development ... into robust clinical drug products. The Sr. Scientist will lead CMC radiopharmaceutical process development, oversee IND-enabling activities, and play a pivotal… more
- Takeda Pharmaceuticals (Brooklyn Park, MN)
- …You will also represent the drug product process science perspective in regulatory CMC interactions, translating process understanding into clear and defensible ... unit leaders + Local Technical Services organizations + Global Quality and Regulatory CMC teams + Ensure process knowledge is captured, shared, and reused across… more
- Takeda Pharmaceuticals (Boston, MA)
- …roles, with deep expertise across Pharmaceutical Sciences + Strong understanding of CMC processes, GxP, regulatory compliance and global quality standards + ... & Technology (DDT) portfolio driving innovation and operational excellence across the CMC lifecycle. This leadership role is accountable for shaping and delivering… more