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The Project Manager, CMC Regulatory Affairs will be responsible for the CMC regulatory activities in the investigational, late phase development and/or early commercial lifecycle management of GSK products.
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What we look for: A scientific degree with directly relevant professional experience in global CMC regulatory affairs and CMC technical areas of at least 20 years with a BA/BS, MA/MS, PhD or PharmD. Demonstrated organizational leadership skills at both functional and enterprise levels.
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We are now looking for a Regulatory Data Office (RDO) Analytics and Reporting Senior Developer to join us in Global Regulatory Operations (GRO) within Regulatory Affairs.
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High School Diploma/GED from AND ten (10) years of (combined product stewardship, regulatory affairs, or EHS experience in a private, public, government or military environment. Bachelor’s Degree or higher AND three (3) years of combined product stewardship, regulatory affairs, or EHS experience in a private, public, government or military environment.
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The CMC Regulatory Affairs Sr. Manager at Gilead is responsible for providing strategic direction, operational support, and technical expertise for. Initiates process improvements and contributes to global process improvements, which have a significant impact for the Regulatory Affairs CMC Department or development matrix teams.
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Internal client groups include the land management; right-of-way; corporate real estate; municipal permitting; and legislative, public, and regulatory affairs teams. Providing comprehensive legal counseling on time-sensitive land and real estate matters to SDG&E business personnel at all levels, including land management representatives; right-of-way agents; lease administrators; real estate advisors; municipality advisors; legislative, public, and regulatory affairs managers; project managers; and upper management and executive teams.
$301,800 a yearFull-timeExpandApply NowActive JobUpdated Yesterday - UpvoteDownvoteShare Job
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Develop effective collaborations with research project leaders and projects team members, including biostatistics, regulatory affairs, clinical pharmacology, clinical scientists and development operations.
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Invenergy is seeking a knowledgeable and proactive Senior Manager for Government Affairs to support our growing Public Affairs team. As a Senior Manager, California Government Affairs, this individual will focus on Invenergy’s California government affairs activities for all aspects of Invenergy’s growing business.
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The Global Scientific Affairs COVID & Flu Senior Manager will play a key role in delivering in-house RWE projects and support the development of Vaccines and Antivirals strategy to keep up with the evolving RWE landscape.
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In this role, a typical day might include:The Regulatory Intelligence Manager performs proactive global monitoring and surveillance of changes in the regulatory landscape focused on the drug development lifecycle, i.e., preclinical through commercialization, as well as disseminate relevant regulatory intelligence information to Regeneron stakeholders.
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Advanced life science degree or certification in Regulatory Affairs Sciences preferred. The Regulatory Intelligence Manager will also facilitate processes to hold cross-functional discussions and coordinate commenting on industry draft policy documents open for public consultation.
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Takeda Development Center Americas, Inc. is seeking a Manager, Global Regulatory Affairs CMC Submissions Management in Lexington, MA to establish global submission activities and timelines in partnership with global and cross-functional stakeholders in Pharmaceutical Science, GMS, Biologics and Small Molecule operating units, Regulatory Affairs, and QA. Up to 20% domestic travel required.
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Position SummaryThis position is a key leadership role for the development of the In Vivo franchise at CRISPR. Reporting to the Senior Director of Regulatory Affairs CMC, you will work closely with cross-functional teams and partners to bring multiple novel therapies to patients.
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The Senior Program Manager of Advocacy will work as a part of a close-knit team to represent PHD & AHF in a way that is accurate and promote public health affairs. A Senior Program Manager of Advocacy enhances the reputation of AHF by representing AHF at local and state government meetings.
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Reporting to the Senior Director for Federal Affairs, the Senior Manager will assist with research and direct lobbying to support AIA’s federal legislative agenda. In collaboration with the Senior Director for Federal Affairs, coordinate with key staff members to build grassroots and grasstop support for AIA’s advocacy agenda.
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regulatory affairs senior manager jobs Company: Capital One
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