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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 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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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 position is responsible for leading CMC regulatory activities within the Regulatory Affairs department, to support all ORIC’s clinical development programs of oncology products.
$235,000 a yearFull-timeExpandApply NowActive JobUpdated 18 days ago - UpvoteDownvoteShare Job
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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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Partner with Drug Metabolism and Pharmacokinetic (DMPK) and Bioanalytical (BA) Subject Matter Experts (SMEs) to author, review and track regulatory documents. Understand the impact of DMPK/BA and interdependencies with other functional teams within the enterprise including Pharmacology, Toxicology, Clinical and Regulatory disciplines.
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More details on our benefits can be found on our website at to the Chief Compliance Officer, the Assistant General Counsel - Regulatory Affairs provides legal support to each of ITW’s Segments and Corporate functions as needed on a variety of regulatory matters, with a principal focus on monitoring and advising ITW businesses regarding existing and developing legal and regulatory issues affecting the company’s operations and products.
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Balance reporting requirements to multiple constituencies including; Centene Corporation regional vice president, state health plan president, chief operating officers and Corporate regulatory and government affairs staff.
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Associate Director, CMC Regulatory Affairs. The CMC Regulatory Associate Director, Biologics is responsible for content development, compilation, maintenance, and review of the Quality Module for regulatory submissions to support biologics products regarding: Clinical trial applications; New marketing applications; HA responses & background packages (including participating/leading HA meetings); and/or post-approval submissions.
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Specific responsibilities include Quality Systems, FSMA, HACCP, GFSI/BRC, regulatory audits, food safety training, Regulatory Affairs, Plant Quality Assurance, Vendor Compliance, and Consumer Affairs.
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The Betr team is looking for a State Government Affairs Lead to support their efforts in shaping the regulatory landscape for online sports betting, fantasy sports, & iGaming in the United States.
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Communicate regularly and effectively in a cross-functional matrix with development, origination, fundamentals, finance, and political & regulatory affairs staff to translate regulatory and market issues into business impacts and opportunities to benefit the position of Pattern's new and core business interests in MISO and other priority markets.
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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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SummaryThe Regulatory Affairs Specialist will reside within strategic business unit, Huber Specialty Minerals (HSM), at Huber Engineered Materials (HEM). Serve as primary contact for HSM hazard communication support and collaborate with HEM regulatory affairs for SDS/Labeling support.
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Two (2) years of progressively responsible experience in regulatory affairs, legislative affairs, or energy policy at an electric utility, regulatory agency, or legislative office.
$179,257 a yearFull-timeExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
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Advanced life science degree or certification in Regulatory Affairs Sciences preferred. 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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regulatory affairs jobs Title: regulatory affairs project manager Company: Gilead Sciences
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