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We are seeking a global Executive Director, Regulatory Affairs, Gene 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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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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He/she works closely with Director, Clinical Supplies, Clinical Operations, Clinical Research, CMC, Regulatory Affairs CMC, Supply Chain, QA, Finance and contracted CROs and external clinical supply vendors to forecast and manage clinical supply and ancillary supply needs and timelines for clinical trials.
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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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Concentra also provides contract services at employer worksites and Department of Veterans Affairs community-based outpatient clinics. We have a clinical team of PTs offering specialty services such as oncology, lymphedema, spine, pain management, ACL program, vestibular, work conditioning/hardening and MORE.
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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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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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Experience in the financial industry demonstrating knowledge of regulatory reporting and analytical skills is preferred. FINRA is a registered trademark of the Financial Industry Regulatory Authority, Inc.
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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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A minimum of two (2) years' experience in a pharmaceutical, biotechnology and/or clinical environment which includes medical and regulatory technical writing/editing (Desired) Protocol Data Abstractor.
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Proven track record of developing strong partnerships, landscaping business opportunities and managing winning proposals to US government departments and agencies, such as Health and Human Services, Defense, Commerce, NIH, Veterans Affairs, etc.
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This entails overseeing areas such as manufacturing, quality, process & analytical development, supply chain, and regulatory affairs. This entails overseeing areas such as manufacturing, quality, process & analytical development, supply chain, and regulatory affairs.
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Serves as a Criminal Investigator in the Office of the Inspector General with the responsibility under the direction of the Assistant Inspector General for Investigations, to perform such investigations and event inquiries as may be required to assure the integrity of operations of the U.S. Nuclear Regulatory Commission (NRC) and Defense Nuclear Facilities Safety Board (DNFSB.
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Aligns w/ cross functional teams for Medical, Commercial, Government Affairs in support of Opioid Antagonists. 5-10 years Medical Affairs experience in the pharmaceutical or biotechnology industries.
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regulatory affairs jobs Title: assistant Company: Citi in Germantown, MD
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