- Sanofi Group (Framingham, MA)
- …and CMC requirements. The role will provide scientific expertise supporting CMC regulatory guidance with innovative approaches to process and analytical ... global CMC projects. + 5+ years of experience with CMC regulatory guidance specific to process/analytical comparability and health authority submissions. +… more
- Takeda Pharmaceuticals (Boston, MA)
- …evolving international regulatory requirements (eg, IDMP, SPOR, XEVMPD, eCTD, ePI, PQ/ CMC , CTIS, ESMP) and assess their impact on RIM data. **3. Collaboration & ... technical data concepts into business terms. + Experience with regulatory domains such as Labeling, CMC , and broader Regulatory Affairs processes. + Exposure… more
- Lotte Biologics USA LLC (Syracuse, NY)
- …antibody drug conjugates with scale-up knowledge is required + Experience with CMC regulatory activities in relevant areas such as analytical characterization, ... relevant conjugation chemistries and to transition bioconjugation processes from research to CMC development, as applicable, to champion manufacturing in support of … more
- Adecco US, Inc. (Morristown, NJ)
- Adecco Healthcare & Life Sciences is seeking a skilled ** CMC Regulatory Technical Writer II** to support a global pharmaceutical client in lifecycle management ... relevant experience level **Key Responsibilities:** + Author and develop CMC sections of regulatory dossiers (Modules 2 and 3) for development and post-approval… more
- Gilead Sciences, Inc. (Foster City, CA)
- …& Manufacturing (PDM) and partner with Quality, Supply Chain, Manufacturing, CMC Regulatory Affairs, Clinical Development and Technical Development to ... analytical deliverables. + Serve as an author and reviewer of CMC sections in regulatory filings, and support interactions with health agencies. + Collaborate… more
- CSL Behring (King Of Prussia, PA)
- …connects and maintains relationships with GRAST members, including GRAS Regions and Regulatory CMC . + Proactively fosters and promotes effective relationships ... therapies that make a meaningful difference worldwide. **Position Description Summary:** Regulatory leaders who leverage regional regulatory experience to… more
- Sanofi Group (Cambridge, MA)
- …+ Ensure good communication and cooperation among different functional groups, including CMC Dossier, Regulatory CMC , Research Platform, and Manufacturing ... Ability to operate independently and to prioritize + Familiarity with cGMP and regulatory requirements on analytical methods + Prior CMC project management… more
- AbbVie (Irvine, CA)
- …+ Author and review CMC analytical sections of BLA and other CMC regulatory packages. Develop strategies for addressing health authority inquiries. + Provide ... supports manufacturing, process transfer/optimization/characterization/validation, analytical method transfer/optimization/validation, product characterization, regulatory submission, and continuous improvement for late-stage and commercial… more
- Genentech (South San Francisco, CA)
- …drug product, analytical development & quality control, device and delivery, regulatory CMC , manufacturing sciences, and clinical and commercial manufacturing ... and regulatory expectations. Additionally, you will oversee portfolio execution, CMC project management, and a team of technical development leaders ( CMC… more
- Sanofi Group (Cambridge, MA)
- …in early and late stage, development of multiple modalities; experience within regulatory CMC not directly applicable. + Demonstrated experience with preparation ... **Job Title:** Regulatory Strategist **Location:** Morristown, NJ/Cambridge, MA **About the...accelerate progress. As a key member of the Global Regulatory Team (GRT), and strategic partner to the Global… more