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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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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.
$113 an hourFull-timeExpandApply NowActive JobUpdated Yesterday - UpvoteDownvoteShare Job
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Comprehensive understanding of related disciplines (biostatistics, regulatory affairs, pharmacology, toxicology, cell therapy manufacturing, clinical pharmacology, and pharmaceutical sciences.
$350,000 a yearExpandApply NowActive JobUpdated 13 days ago - UpvoteDownvoteShare Job
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Our client is looking to fill the role of CMC Regulatory Affairs Manager. Provide CMC regulatory strategy for investigational, new and marketing products (biologics and small molecule focus.
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The Federal Legislative Affairs Director - Energy provides leadership on policy advocacy, and strategic planning to Duke Energy on federal regulatory issues. Collaborates with Duke Energy management and various business unit personnel ( e.g. , energy policy, regulated utilities, gas operations, renewables, energy delivery, compliance, corporate communications, and legal) in identifying and prioritizing federal regulatory issues of concern to the company and formulating single company positions related to those issues.
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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 11 days ago - UpvoteDownvoteShare Job
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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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HJF is seeking a Regulatory Affairs Specialist to assist in the compliance of HJF research programs with applicable local, state and federal regulations for human subjects research, animal use research, recombinant DNA, and Health Insurance Portability and Accountability Act (HIPAA.
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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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Job : Govt, Corp, & Regulatory Affairs. Job Description - Mgr Revenue Requirements (Regulatory Accounting Manager) (254223) Analyze, interpret and communicate accounting and financial planning impacts due to regulatory commission rate case decisions and rulemakings regarding distribution, transmission, supply, and surcharge revenue, ratemaking, and cost recovery matters.
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The Wounded Warrior Project (WWP) Government Affairs Deputy Director assists in the development and implementation of WWP’s public policy strategy to advance its legislative, regulatory, and advocacy priorities.
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A summer internship is available in the Regulatory Affairs CMC (chemistry, manufacturing and controls) Department at the Foster City, CA, campus of Gilead Sciences. Intern - CMC Regulatory Affairs - Biologics.
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This individual will work collaboratively with members of all departments within the company, including but not limited to Offshore Wind Development, Onshore Development, Origination, Transmission, Regulatory, and Environmental Compliance & Strategy.
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We are seeking an innovative and highly motivated Principal Scientist, Scientific Affairs who will contribute significantly to the development and continued growth of our advanced cell therapy manufacturing platform.
$210,000 a yearFull-timeExpandApply NowActive JobUpdated Yesterday - UpvoteDownvoteShare Job
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Identify energy policy needs for Invenergy in CA, in alignment with Invenergy's corporate goals and in coordination with the public affairs team in CA, as well as other Invenergy departments and companies.
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regulatory affairs jobs Company: Altor Solutions in Beech-grove, Indiana
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