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Minimum 5 years in Regulatory Affairs within any of the following industries: pet food, food, OTC drugs, medical devices or pharmaceuticals; Create and foster a climate of teamwork and effective working relationships both within Regulatory Affairs and with our internal business partners: Quality, Marketing, Legal, New Product Innovation, Science & Technology, Professional Veterinary Affairs, Supply Chain, and others to achieve the synergy needed to effectively work as a team and promote the business.
$128,000 - $150,000 a yearFull-timeExpandApply NowActive JobUpdated 9 days ago - UpvoteDownvoteShare Job
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The Regulatory Affairs Associate, as a member of the Clinical Trials Support Unit of the DLDCCC, works to provide regulatory compliance and study start-up support to physician investigators in one or more designated oncology disease areas.
$68,000 - $78,514 a yearFull-timeExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
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Reporting to the Regulatory Affairs Manager, the Regulatory Affairs Specialist will, with minimal supervision, prepare and process all regulatory documentation through the IRB, CTSRMC, FDA and all applicable regulatory review committees- including new submissions, continuing reviews, amendments, adverse events, and reportable events.
$51,824 - $63,600 a yearFull-timeRemoteExpandApply NowActive JobUpdated 5 days ago - UpvoteDownvoteShare Job
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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.
$100 - $113 an hourFull-timeExpandApply NowActive JobUpdated 3 days ago - UpvoteDownvoteShare Job
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Provide CMC expertise in the Editas regulatory affairs organization by keeping abreast of global CMC regulatory requirements and ensure that project team colleagues and management are informed of developments opportunities and risks that may impact regulatory success.
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Represent Regulatory Affairs in project teams. Senior Regulatory Affairs. Strong with pharmaceutical guidelines, eCTD software and submissions, GMP, USDA, EU and other regulatory requirements, NF pharmacopeia, EP monographs, and pharmacovigilance guidelines.
Full-timeExpandApply NowActive JobUpdated 16 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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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.
Full-timeExpandApply NowActive JobUpdated 26 days ago - UpvoteDownvoteShare Job
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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.
Full-timeExpandApply NowActive JobUpdated 3 months ago - UpvoteDownvoteShare Job
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Experience in Regulatory Affairs and/or Quality Assurance in mortgage servicing, previous complaint handling experience strongly preferred. Requires continuous learning and keeping up to date with the Regulations related to the Real Estate Settlement Procedures Act (“RESPA”), Truth in Lending Act (“TILA”) the Fair Credit Reporting Act (“FCRA”), the Consumer Financial Protection Bureau (“CFPB”), and policies and procedures regarding Fraud/ID Theft.
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This position will report to the Executive Director of Regulatory Affairs CMC. Ultragenyx is seeking a highly motivated Senior Director, Regulatory Affairs CMC, who is a team builder and enjoys a fast-paced, dynamic work environment.
$234,900 - $290,200 a yearFull-timeExpandApply NowActive JobUpdated 2 months ago - UpvoteDownvoteShare Job
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Serve as the Plan’s internal Compliance point of contact for Regulatory Affairs matters. Under the direction of the Manager, Regulatory Affairs assist in preparing the Plan for regulatory audits.
$30.72 - $39.94 an hourFull-timeExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
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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.
Full-timeExpandApply NowActive JobUpdated 28 days ago - UpvoteDownvoteShare Job
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Tessenderlo Kerley, Inc. is adding an additional Regulatory Affairs Manager to join their talented Regulatory team. As a Regulatory Affairs Manager, you will interact with internal and external customers, including state/provincial and federal regulatory authorities, in support of NovaSource products.
$7,500 a yearExpandApply NowActive JobUpdated 11 days ago - UpvoteDownvoteShare Job
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Supports the office and related campus leaders by overseeing case management and assisting with the following responsibilities: record keeping, on-campus training, prompt & effective investigations, student and employee accommodations and leave, and related programmatic support to ensure that UTSW complies with all statutory and regulatory obligations under Title VII, Title IX, Clery Act, VAWA, SB212, UTSW policies, and any other applicable federal or state laws and regulations.
Full-timeExpandApply NowActive JobUpdated 28 days ago
regulatory affairs record keeping jobs Title: regulatory affairs coordinator
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