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... from scientists, and authoring the CMC sections of regulatory documents (e.g., ... global Health Authorities on the CMC sections of regulatory documents. These ... Evaluation, and Global Regulatory Sciences..
... results. Functional Area Description The GRS-CMC organization provides regulatory expertise related ... provides regulatory expertise related to CMC activities through all stages of ... the organization develop global regulatory..
Bristol-Myers Squibb is a global Biopharma company committed to a single mission: to discover, develop, and deliver innovative medicines focused on helping millions of patients around the world in disease areas ..
nnTitle: Manager/Senior Manager, Manufacturing SciencesReports To: Vice President, ... City, CaliforniaClassification: Exempt Overview: nThe Manager/Senior Manager, Manufacturing Sciences will be responsible ... Substance (DS) manufacturing processes. The Manager/Senior Manager will..
JOB SUMMARY Step up and lead with a regional leader. Advance your career with an award-winning organization that excels in helping our communities stay healthy and our region grow stronger. Make ..
Why Join Intellia? Our mission is to develop curative genome editing treatments that can positively transform the lives of people living with severe and life-threatening diseases. Beyond our science, we live ..
nMyovant Sciences aspires to be the leading healthcare company focused on innovative treatments for women’s health and prostate cancer designed to improve the lives of millions. We are on a mission ..
... the Chemistry, Manufacturing and Controls (CMC) aspects of regulatory documents and ... Partners). Responsible for developing global CMC regulatory strategy (e.g., CMC strategy/planning for NMEs), driving global ... strategy/planning..
... life.rnrnI. JOB SUMMARY rnrnThe Project Manager will work closely with cross-functional ... completion of project(s). The Project Manager is accountable for maintaining project ... contact for the project (i.e.,..
... point of contact on the CMC (Chemistry, Manufacturing and Controls) team ... a core member of the CMC team, the PQL provides efficient ... and effective quality leadership of..
... who will be accountable for CMC product strategy to enable advancement ... include leading or managing the CMC PST, representing CMC at Vir Program Team meetings, ... alliance partnerships..
... the United States by providing CMC Regulatory leadership and establishing Civica's ... Affairs systems and processes. The Manager, Regulatory Affairs CMC:nnProvides CMC regulatory leadership and support for ... programs..
... The Clinical Supply Chain Operations Manager is responsible for supporting clinical ... Supply Chain Operations (CSC Ops) Manager translates clinical trial assumptions into ... clinical trial. The CSC Ops..
Regulatory CMC Biologics Manager The GCMC manager possesses CMC regulatory knowledge and quality expertise ... risks.Preparation &Delivery of high quality CMC regulatory submissions & submission management ... portfolio. ●ROLE RESPONSIBILITIES..
Who We Are From research and discovery to post-market clinical development, our WWRD engine involves all bench and clinical research and the associated groups that support those endeavors. Our teams work ..
At Bristol Myers Squibb, we are inspired by a single vision - transforming patients' lives through science.In oncology, hematology, immunology and cardiovascular disease - and one of the most diverse and ..
The Role:Moderna is seeking a Quality Assurance Manager reporting to the Sr. Manager Quality Assurance. The individual in this role will be responsible for providing Quality leadership & support and lead ..
Associate Manager, Regulatory Publishing (BASKING RIDGE, NJ)Regeneron Pharmaceuticals, Inc. is seeking an Associate Manager, Regulatory Publishing (Basking Ridge, NJ) to oversee the formatting and publishing of electronic documents. Manage the building ..
... lives. For an assigned product,The CMC submission managers support and may ... parts of the development of CMC strategy and plans; the planning, ... planning, preparation, and submission of..
... Summary:rnrnThe Director and Head of CMC Regulatory Affairs leads the successful ... specific industry experience regarding the CMC Regulatory requirements.rnrn rnrnThe Director and ... rnrnThe Director and Head of..