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May develop Standard Operating Procedures (SOPs) and Work Instructions (WIs) as directed by the Senior Director CMC Regulatory Affairs. Prior pharmaceutical industry experience and a minimum of 8 years in CMC Regulatory Affairs for Associate Director.
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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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Requirements: BSc or MSc level degree preferably within the life sciences (PharmD, PhD preferred) Minimum of 5-8 years of hands-on industry experience within Regulatory Affairs (Oncology and/or immunology and inflammation is preferred) Prior experience of direct interaction/negotiation with regulatory authorities (e.g. FDA, EMA) A solid understanding and experience in drug development including early and late development is highly preferred.
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JOB DESCRIPTION Job TitleSr. Regulatory Affairs Specialist-CT/AMIJob DescriptionThe Senior RA Specialist will play a critical role in ensuring Philips Computed Tomography (CT) and Advanced Molecular Imaging (AMI) solutions are safe, reliable, and compliant through driving global regulatory strategy and regulatory roadmaps—understanding competitive claim landscape, legislative initiatives, and marketing strategy.
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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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Collaborate with key stakeholders and cross-functional partners (Development, Safety, Regulatory Affairs, HEOR, Medical Affairs, Precision/Molecular Medicine, and Genetics Research Center) to propose and execute on epidemiology and RWE studies that support key asset strategy needs.
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The Manager of Regulatory Affairs at AES Clean Energy (AESCE) will be tasked with supervising AESCE's positions and fostering relationships within the Federal Energy Regulatory Commission (FERC), managing policy positions within Regional and Independent Transmission Organizations (RTO/ISO), and taking the lead on filings and policy positions at state Public Utility Commissions (PUC) or Public Service Commissions (PSC) in key states.
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Regulatory Affairs Manager (Medical Device/Cosmetic) - Long Beach, California page is loaded. Regulatory Affairs Manager (Medical Device/Cosmetic) - Long Beach, California. Serves as the internal subject matter expert for international regulatory affairs on assigned projects/regions, including labeling review.
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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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Cross-functional clinical processes, including data management, biostatistics, medical writing, drug safety/pharmacovigilance, and regulatory affairs. Negotiates cross-functionally, successfully motivates and influences (Clinical Development, Regulatory Affairs, CMC, QA, Pharmacovigilance, etc.
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10+ years of prior working experience in electric regulatory affairs and policy advocacy required, preferably in the ERCOT region. Hunt Energy Network (HEN) is seeking a highly motivated, trustworthy individual with experience working independently to serve as HEN's Director of Regulatory Affairs.
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OPPORTUNITY Mammoth is hiring a Director/Sr. Director, Regulatory Affairs, Therapeutics, to lead the regulatory activities of our growing CRISPR-based therapeutic programs as we bring them from concept to market.
$205,000 - $260,000 a yearExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
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You're the right fit if: You’ve acquired a minimum of 7 years' Regulatory Affairs experience within FDA regulated, complex Medical Device/Software (SiMD/SaMD) environments, including leadership/guidance on global regulatory strategy for 510K’s, CE Marking per MDD, EU MDR (updating Technical Files), Worldwide product registrations, Design Dossiers, PMA, clinical evaluations, Post Market Surveillance and reviewing Marketing Communication materials for promotional purposes.
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The Director, Transmission Policy Advocacy be based out of Invenergy’s Washington, D.C. office and report to the SVP, Transmission Public Affairs while collaborating closely with Invenergy’s federal affairs, regulatory, permitting, and transmission business functions.
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Represent Humana at regional and national legislative, regulatory and other intergovernmental organizations in coordination with State Affairs policy team. Minimum of ten or more years of professional experience in state government, government affairs, campaign, health policy and/or advocacy roles.
$185,000 - $190,000 a yearFull-timeExpandApply NowActive JobUpdated Today
regulatory affairs jobs Company: Aegon Asset Management
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