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We are seeking a global Executive Director, Regulatory Affairs, Cell Therapy (level determined by candidate experience) reporting into the SVP Clinical Operations who will serve as the strategic lead representing regulatory affairs expertise managing the strategy and operational aspects of all regulatory submissions (INDs, NDAs, MAAs, etc.
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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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Providing advice on regulatory issues for both marketed and pipeline products; actively collaborates with management, Global Regulatory Lead and cross functional colleagues within Alexion (i.e., commercial, research, clinical development, medical affairs, business development, legal, manufacturing, quality, portfolio management, financial, human resources, etc.
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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.
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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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Concentra also provides contract services at employer worksites and Department of Veterans Affairs community-based outpatient clinics. Attend and/or participate in facility meetings as directed by the center manager.
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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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Collaborate with clients, regulatory agencies, and internal teams, including VIKA’s Engineering, Landscape Architecture, Surveying, and Planning Staff, as well as external consultants, to facilitate project coordination and communication.
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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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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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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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As a Director, Regulatory Affairs, Vaccines you will ensure 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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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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You will also ensure that operations are aligned with the cGMP standards established by AstraZeneca and relevant regulatory agencies. - Extensive working knowledge of international Cell Therapy GxP regulatory frameworks, regulations, and guidance.
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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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regulatory affairs jobs Title: regulatory affairs project manager Company: Aerotek in Germantown, MD
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