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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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As a Director, Regulatory Affairs, Vaccines you will e nsure the development and execution of the appropriate Regulatory strategy(ies) for assigned US asset(s), across all stages of the product life cycle and consistent with the Vaccines Development Strategy/Integrated Asset Plan (IAP.
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Lead and shape future clinical development strategy and clinical development plans, working closely with Development and Discovery Program Leads and counterparts in Regulatory, Clinical Development, Clinical Operations, Biostatistics, Clinical Pharmacology, Medical Affairs, Commercial, Non-clinical and Discovery Research for assigned studies.
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Electrical System Design: Evaluate and design electrical, avionics and related systems for Hughes' broadband internet connectivity product, ensuring those designs meet performance, safety, and regulatory requirements.
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The Montgomery County Department of Housing and Community Affairs (DHCA) is currently seeking to fill two Housing Code Inspector positions. Montgomery County Government is an equal opportunity employer, committed to workforce diversity.
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Participate in community affairs and maintain positive public image for the property and HEI Hotels and Resorts. For your physical and mental wellness we offer competitive Medical and Dental programs through Anthem Blue Cross Blue Shield as well as Vision insurance programs through EyeMed. Our Vacation, Sick and Holiday programs are available for you to rejuvenate with time off.
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Lead, set the strategy and when appropriate write the key pharmacovigilance documents, including but not limited to, medical safety assessments, regulatory responses. Apply current regulatory guidance as appropriate for safety surveillance and authorship of safety documents.
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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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Do you have previous experience in animal care and/or control (e.g., animal services officer, veterinarian assistant, attendant at an approved kennel) or regulatory compliance and enforcement, law enforcement, military, or related field.
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Training Requirements for the 1811 Series: The Nuclear Regulatory Commission's Office of the Inspector General (NRC OIG) will not sponsor candidates for the Federal Law Enforcement Training Center (FLETC) Criminal Investigator Training Program (CITP.
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Develop constellation modeling and analyses for LEO/MEO/GEO satellite systems and conduct analyses against regulatory masks. This is an exciting position where the candidate will be involved in design and testing of state-of-the-art RF and phased-array antenna systems for next generation LEO/MEO/GEO satellite communication systems.
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You will drive interactions with key stakeholders across the business including but not limited to Safety Science, Clinical Pharmacology, Business Process Operations, Therapeutic areas, Patient Safety, Quality Assurance and Regulatory Affairs.
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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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Successful candidate is expected to use a variety of cellular, molecular biology and biochemical knowledge, and the latest CMC technical, regulatory and project management experience to transition new candidates into CMC development to enable human clinical trials.
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Assists the Director and Senior Director with audit commitment tracking, Regulatory Liaison work, and regulatory compliance-related initiatives. The Senior Regulatory Operations Analyst is an advanced-level professional position responsible for a wide range of tasks in support of various regulatory compliance functions in Market Regulation and Transparency Services (MRTS), including those related to managing conflicts of interest-related compliance issues and inquiries and maintaining department-wide administrative policies and procedures.
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regulatory affairs jobs Title: sr director Company: Govhr Usa in Gaithersburg, MD
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