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The Principal Scientist provides regional scientific and regulatory expertise and leverages scientific networks to enable the development and execution of Mars Wrigley (MW) Scientific and Regulatory Affairs (SRA) strategy.
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Within Global Regulatory Affairs, our Chemistry, Manufacturing and Controls (CMC) organization provides regulatory leadership to CMC development teams and the Pharma Supply Chain organization to enable approval of new medicines and uninterrupted supply of our medicines to patients.
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A scientific degree with directly relevant professional experience in global CMC regulatory affairs and CMC technical areas of at least 15 years with a BA/BS, MA/MS, PhD or PharmD. Demonstrated track record in leading CMC regulatory affairs initiatives, innovative CMC regulatory strategies, and leadership in international regulatory/industry forums for topics of external policy relevance (e.g., ICH, PhRMA, ISPE, IQ, Bios, etc.
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Duties Description As a member of the Executive Chamber, the Associate Director of Legislative Affairs reports to the Assistant Secretary for Legislative Affairs and plays a role in keeping the Governor and Secretary informed about matters related to the New York State Legislature.
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A scientific degree with directly relevant professional experience in small molecule development, global CMC regulatory affairs and CMC technical areas of at least 16 years with a BA/BS or 14 years with an MA/MS, PhD, PharmD, or MD.
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Provide expert technical and consulting support, regarding OPWDD regulations, ACLD policies and procedures in regulatory affairs related programs and other complex related matters to the ACLD workforce.
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Lead the execution of global CMC regulatory plans, including overseeing the submission and approval process in close partnership with other functions in PDM, Regulatory Affairs, and Clinical Development.
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If so, this Director of Regulatory Affairs, CMC could be an exciting opportunity to explore. Ensures all appropriate CMC regulatory aspects across teams to support change control requests including transfer of supply within GSK or with a 3rd party are delivered to agreed timelines.
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Partner closely with Bristol Myers Squibb government affairs teams to advance policies in support of patients. The role is expected to serve as a liaison between the Bristol Myers Squibb Corporate Affairs, Investor Relations, and Issues Advocacy teams and RayzeBio. It requires the ability to navigate between the culture of small biotech while integrating with a broader corporate structure.
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Executive Office support: serves as Chief of Staff to the VP, Head of Alexion Regulatory Affairs, supporting internal and external engagement and managing activities as part of the function's Executive Office.
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Responsible for Assessment and Authorization (A&A) activities for Consular Affairs / Consular Systems and Technology (CA/CST) automated information systems (AIS) and provides A&A support for domestic and oversea deployed systems, as well as A&A activities on Cloud systems (IAAS, SAAS, and PAAS.
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15+ years of pharmaceutical/biotech drug development experience with 5+ years of experience in global CMC regulatory affairs with working experience and content knowledge in CMC development of NCEs/small molecules.
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Dorsey and Whitney LLP is seeking a Regulatory Affairs Associate with four to six years of experience to join the Anchorage office. Regulatory Affairs Associate (#856.
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AURORA UNIVERSITY PROVOST AND EXECUTIVE VICE PRESIDENT FOR ACADEMIC AFFAIRS Aurora University (AU), a private university located in Aurora, Illinois, invites nominations and applications for the position of Provost and Executive Vice President for Academic Affairs (Provost.
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The Associate Director of Legislative Affairs also serves as a liaison for New York State Legislative Issues. Undertake specialized projects and in-depth studies as directed by the Deputy Secretary or Assistant Secretary for Legislative Affairs.
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affairs job Title: regulatory affairs associate Company: Thermo Fisher Scientific
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