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Experience with regulatory documentum software (CARA, eSub, etc) is strongly preferred along with proficiency in compliance ready standards for final publication. Responsibilities Initial draft authoring of scientific content for Common Technical Document (CTD) Quality sections and responses to health authority questions aligned with regulatory strategy for cell therapy clinical CMC regulatory submissions based on high quality technical reports.
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Ensure Equipment Compliance: Receive and review revisions to USP, EP, JP, FDA regulatory guidelines. The incumbent in this individual contributor role ensures the compliance of equipment and the ECQ group with local, global, and regulatory guidelines.
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Act in compliance with Heritage Healthcare’s regulatory and professional standards and guidelines. The Physical Therapy Assistant is a skilled technical worker who performs direct resident care activities under the clinical supervision of the Physical Therapist.
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Comprehensive understanding of ICH-GCP guidelines and international regulatory frameworks, with proven track record of applying these standards in clinical research and contractingDemonstrated success leading and directing the global supply market evaluation process using all available market intelligence, risk, compliance, and financial assessment tools.
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Collaborate with clinical and non-clinical departments to enhance patient-centered care and improve patient satisfaction value-based care goals, regulatory compliance ratings, and recognitions.
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Monitor legislative and regulatory tax law developments, communicate the effects of these developments to management and the tax team and create strategies to capitalize on changes to taxation legislation.
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They are accountable for execution of all applicable risk programs (Credit, Market, Financial Crimes, Operational, Regulatory Compliance), which includes effectively following and adhering to applicable Wells Fargo policies and procedures, appropriately fulfilling risk and compliance obligations, timely and effective escalation and remediation of issues, and making sound risk decisions.
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Pharmacy Technicians take important steps to ensure all medication needs and regulatory compliance standards are met for our patients and they demonstrate ethical conduct and maintain patient confidentiality at all times.
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The Team Member will work closely with colleagues to prepare fresh and hot food, deliver 5-star guest service, clean and maintain the restaurant, and conduct other duties assigned by the Restaurant Management Team. This role manages payments responsibly, adheres to food service standards, and ensures cleanliness of all aspects of the restaurant in compliance with all policies, procedures, and regulatory requirements.
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These responsibilities include but are not limited to financial management, hiring, supervising, training, team member relations and recognition, communication, family services, resident well-being, quality assurance, and regulatory compliance.
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All positions must strive to support WFM core values and goals, promote national, regional, and store programs and initiatives, and ensure adherence to all applicable health and safety regulations including Food Safety and regulatory duties required in the department.
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Ensure the achievement of cost, productivity, accuracy, or timeliness objectives (department KPIs) Monitor product import or export processes to ensure compliance with regulatory or legal requirements Elaborate and manage improvement projects within the logistics area Handling of change management topics Support inventory management consisting of reconciling and maintaining of finished goods Oversee and monitor availability of stock.
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The Director of Regulatory Affairs will oversee a team of regulatory specialists and collaborate closely with clients, internal teams, and external stakeholders to achieve regulatory compliance and facilitate successful product development and market access.
$261,000 a yearFull-timeExpandApply NowActive JobUpdated 26 days ago - UpvoteDownvoteShare Job
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5+ years of experience in financial services industry, preferably brokerage, trust, fiduciary, wealth, and investment management and involvement in regulatory reporting activities. There is emphasis on proactive monitoring, governance, risk identification and escalation, as well as making sound risk decisions commensurate with the business unit's risk appetite and all risk and compliance program requirements.
$237,100 a yearFull-timeExpandApply NowActive JobUpdated Yesterday - UpvoteDownvoteShare Job
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Lead data migration processes and oversee database closeout activities, ensuring seamless transitions and compliance with regulatory guidelines. Strong knowledge of clinical research, FDA & ICH, GCP, GCDMP, and related regulatory requirements.
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regulatory compliance jobs in Basking Ridge, NJ
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