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A thorough understanding of the complex Regulatory, Development and Medical Affairs requirements in oncology, as well as the emerging paradigm for cell & gene therapy. Precigen is advancing an exciting pipeline of novel cell and gene therapy products and to further our efforts we are seeking an Executive Director, Medical Affairs who will be instrumental in creating and building the global medical affairs function at Precigen for our first commercial launch.
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The Regulatory Affairs Manager (RAM) is a regulatory specialist with project management capabilities responsible for leading the end-to-end planning, coordination, and execution of assigned deliverables.
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The Regulatory Training Specialist works with other training specialists in MRTS and Regulatory Operations to assist in the development, design and delivery of learning solutions that support FINRA's mission of protecting investors and safeguarding market integrity in a manner that facilitates vibrant capital markets.
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Assure effective development, implementation, and monitoring of budgets for assigned management units e.g., speech-language pathology, government affairs and public policy, special interest groups and international affairs.
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Regulatory Toxicology & Safety Pharmacology is a global department within the Clinical Pharmacology and Safety Sciences (CPSS) function; we’re looking to recruit a talented and experienced reproductive toxicologist to join our reproductive toxicology team.
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This individual has strong skills in issue spotting, analyzing, understanding, and translating complex legislative, regulatory and policy issues to advise on pending legislation, regulations, changes in key government policy and other government affairs matters pertinent to Otsuka, and will fully appreciate the relationship between enterprise needs and state policy.
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Collaborate with internal and external legal and policy specialists on various gaming related law and regulatory issues, including privacy, accessibility and digital safety matters associated with the video gaming industry.
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In the preparation and review of bioanalytical data and reports suitable for regulatory submission. in molecular biology techniques such as cloning, site-directed mutagenesis, DNA and RNA isolation and purification, sequencing, RT-PCR, and qPCR.
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15 years of experience in drinking water treatment with at least 5 years in water quality and treatment (water quality analysis, treatment evaluations, process design, regulatory compliance assessments, distribution water quality analysis, etc.
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You will maintain expertise in regulatory requirements and preclinical safety approaches applied to Immuno-Oncology therapeutics and awareness of industry trends. You will contribute to early oncology project decision making, address specific concerns, and present findings to ensure that teams can make the right decisions regarding safety risks that facilitate timelines and regulatory submissions.
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Thorough understanding of the cross functional drug development processes (Clinical Operations, Biometrics, and Regulatory Affairs) and context applicable to safety surveillance activities required.
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The Technical Expert is responsible for understanding the regulatory and policy landscape for genetic biocontrol approaches to control malaria and other vector-borne diseases; planning and implementing a portfolio of activities to provide technical information and advice on regulation and policy to stakeholders; and collaborating with partners to build regulatory and policy capacity, particularly through online and in-person trainings.
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Ability to collaborate with and influence other functional areas such as Manufacturing, Validation and Regulatory Affairs. Provide scientific guidance and oversight while factoring in technical, regulatory, and intellectual property considerations and risk assessment.
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Background in pharmacology, toxicology, pathology, DMPK, drug development, and global regulatory requirements is required. Oversee, design, and report on nonclinical studies in accordance with international regulatory requirements.
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Provide clinical documentation using malaria databases, NIH electronic medical records, and regulatory documentation of events post-vaccination. Must have experience with WHO and FDA regulatory authorities as it pertains to the conduction of human clinical trials.
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regulatory affairs jobs Title: regulatory affairs assistant in Gaithersburg, MD
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