- Takeda Pharmaceuticals (Boston, MA)
- …of what is possible in order to bring life-changing therapies to patients worldwide. The Director Regulatory Site CMC ensures efficient and compliant ... based on risk and scientific rationale. + Facilitate alignment between site teams and global Regulatory CMC on post-approval strategies and activities and… more
- Actalent (Boston, MA)
- Job Title: Director Regulatory CMC Job...a hybrid work option with a preference for working on- site at our Boston, MA office twice a week. ... professional eager to join a collaborative team as a Director /Sr. Director of Regulatory CMC based in Boston with a hybrid option. This role involves… more
- Bristol Myers Squibb (Devens, MA)
- …s general support and leadership within the Global Product Quality organization . The Sr. Director a uthor s designated sections of regulatory filing s , review ... lives. Read more: careers.bms.com/working-with-us . **Position Summary** The Senior Director , Cell Therapy Global Product Quality Lead ( Sr....queries, as needed . + R epresent Quality in CMC meetings with global regulatory agencies and… more
- Bristol Myers Squibb (Devens, MA)
- …and comparability strategies, supporting the authoring of technical sections of major regulatory documents, and contributing to the overall CMC and commercial ... their personal lives. Read more: careers.bms.com/working-with-us . **Position Summary** The Director , DP Tech Transfer owns the technology transfer of the late-stage… more
- Takeda Pharmaceuticals (Lexington, MA)
- …in leading cross-functional clinical programs within Medical Affairs, Clinical Research, Regulatory , CMC or other drug development related function. Clinical ... with significant experience within related functions (eg, Medical Affairs, Clinical Operations, Regulatory , CMC , Marketing). + Minimum of 5 years' experience as… more
- Bristol Myers Squibb (Devens, MA)
- …personal lives. Read more: careers.bms.com/working-with-us . Position: Executive Director , Biologics Drug Substance, Manufacturing Sciences & Technology Location: ... biological products and will be the lead technical representative to global regulatory agencies for these products. The jobholder will chair the Biologics Drug… more
- Bristol Myers Squibb (Devens, MA)
- …for: + Technology transfer and process validation across the product lifecycle + CMC lifecycle management and regulatory strategy + Oversight and governance of ... harmonization, and standardization to ensure global manufacturing scale-up, reliability, and regulatory compliance We are seeking a strong strategic technical leader… more
- Bristol Myers Squibb (Devens, MA)
- …highly complex and/or novel problems. + Responsible for supporting technical aspects of site regulatory inspections with thorough understanding of regulatory ... are designed and validated per applicable current good manufacturing practices (cGMPs), site procedures, and that processes are defined consistent with regulatory… more
- Humana (Boston, MA)
- …operates about 340+ senior focused primary care centers in 15 states. The Regulatory Compliance team that supports the PCO is responsibility to assess, investigate, ... mitigate risks. The Senior Clinical Compliance Professional will support the Director of Compliance, by ensuring compliance with governmental requirements for… more
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