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Piper Companies is currently seeking a Regulatory Affairs Specialist, Cell & Gene Therapy for an opportunity in Philadelphia, Pennsylvania (PA), to join an innovative biotechnology company creating life-saving cell therapies.
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To do these effectively, the Analyst III – Policy & Regulatory Operations must have a demonstrated understanding of IEHP business operations and responsibilities of various departments in Health Services, Quality Systems, Provider Services, and Member Services; subject matter expertise of these departments’ policies and procedures and the regulations that drive their business operations and demonstrated ability to effectively and consistently manage multiple projects and priorities concurrently.
$80,059.2 - $106,059.2 a yearFull-timeExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
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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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Large MLTC program with locations around NYC, is currently seeking an experienced Regulatory Affairs Associate to join their dynamic and dedicated team. Regulatory Affairs Associate – MLTC Program - Hybrid.
$125,000 - $150,000 a yearFull-timeExpandApply NowActive JobUpdated 2 days ago - UpvoteDownvoteShare Job
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May oversee and direct the work of other Regulatory Affairs professionals. Serves as a regulatory liaison for new product development and make regulatory assessments of proposed changes to existing products for impact to regulatory documentation.
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Job Title: Regulatory Affairs Manager. Provide CMC regulatory strategy input and expertise in investigational, new and marketed biologic and small molecule drug products to assigned project teams, to ensure Otsuka’s products are developed/maintained in compliance with global regulatory requirements and guidance.
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Regulatory and QA Specialist Our client is a highly regarded manufacturer of flavors and essential oils. Responsibilities Prepare regulatory documentation for flavors and essential oil products - SDS, Allergen statement, Natural status, GMO, Prop 65, flavor product Ingredient listing, etc.
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As Sr. Manager CMC Regulatory Affairs you will also be responsible for identifying and evaluating CMC issues associated with development products, including product and process development, analytical methods, formulation development, manufacturing, and labeling.
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The Counsel – Regulatory Affairs is responsible for supporting compliance with federal and state laws and regulations. Counsel – Regulatory Affairs will be expected to make significant contributions to the compliance program by providing consistent and effective counsel to the organization.
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As the newest Regulatory Affairs Manager, you will be responsible for registering current and newly acquired crop protection products in the U.S. and other regions (Asia/Pacific, Latin America, Africa, Europe, and Canada.
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Gain experience working cross functionally with regulatory, CMC - Regulatory Affairs, and CMC specific functions. Assist CMC - Regulatory Affairs colleagues with activities supporting CMC key deliverables and regulatory related submissions.
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Depending on specific role, the Associate Director Regulatory Affairs may be involved in various regulatory activities (oversee activities for regulatory submissions; negotiate with regulatory authorities; oversee processes involved with maintaining annual licenses, registrations, ensure external communications meet regulations; lead crisis management program development and implementation; oversee and manage systems related to product safety issues and product recalls, project management, etc.
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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. 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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Washington DC, Department of Consumer and Regulatory Affairs, Board of Industrial Trades, Class 1 – Steam Engineer License MD, Class 1 – Steam Engineer License. Ten (10) years’ experience as a mechanical engineer or journeyman mechanic with field experience in either maritime or industrial plant (construction, operation, or maintenance) as well as one of the following licenses: National Institute for the Uniform Licensing of Power Engineers, Inc. (NIULPE) First Class Power Engineer License.
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Report to the Director/Associate Director/Lead Regulatory Scientist/Sr. Manager Regulatory Affairs. Develop and maintain positive rapport and working relationships with other personnel in Regulatory Affairs, CMR, and other local and headquarter departments to accomplish company goals.
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regulatory affairs jobs Title: regulatory affairs assistant Company: Thermo Fisher Scientific
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