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Partners with support departments such as business development, HR, facilities, and regulatory operations to ensure a successful transition and opening of new sites. Ensures overall compliance with legal, regulatory, and quality requirements.
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Ensure Equipment Compliance: Receive and review revisions to USP, EP, JP, FDA regulatory guidelines. Working knowledge of regulatory guidelines such as FDA, EMA, USP, EP and JP. Excellent computer skills including knowledge of equipment data quality systems.
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Under the direction of Regulatory Affairs management, participate in drug development from early stage development through final formulation, ensuring compliance with principles of Quality-by-Design, cGMP, and FDA rules and regulations.
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A comprehensive understanding of the industry's complex legal and regulatory requirements, best practices in pharmaceutical marketing, and of the dynamics driving the global health care environment, are essential.
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The role leads the US TA insights team across all aspects of identifying key business questions (KBQs), leading the development and execution of an Integrated Insights Plan (IIP) with its various components such as Primary Market Research (PMR), Forecasting (FC), Business Analytics (BA), data strategy, human insights (behavioral science-led) and Competitive Intelligence (CI) in collaboration with internal partners and external vendors.
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In this role, you will provide strategic thought partnership and tactical support to help our clients stay ahead of legislative and regulatory landscape changes. o Legislative Analyst. o Public Affairs Specialist.
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Working knowledge of GMP and regulatory requirements of biopharmaceutical manufacturing is preferred. Understanding of guidelines required by FDA, EMA, and other regulatory bodies. Experience with optimization and statistical data analysis tools such as Minitab, JMP, Spotfire and R. Basic programming in R and Python preferred.
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File all State and Local excise/franchise/business tax returns and US census filings; Maintain copies of completed tax forms and related documents for reporting and auditing purposes; Respond to communication from regulatory agencies.
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Cultivate close relationships with cross-functional team colleagues in Medical Affairs, Regulatory Affairs, Operations, Finance, and Corporate and External Affairs to align on and advance strategic goals.
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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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Description & SummaryA career in our Balance Sheet Management practice, within Financial Risk and Regulatory services, will provide you with the opportunity to help business leaders embed a proactive and dynamic risk management capability and mind set into their corporate business practices.
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This position supports Alvogen’s commercial business, and works closely with Supply Chain, Project Management, Regulatory Affairs, Sales and Marketing, and external suppliers and partners. ORGANIZATION STRUCTUREThe QA Manager Operations, Third Party reports to the Associate Director, Operations of Third Party U. S. Quality.
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12+ years of experience in regulatory affairs within the pharmaceutical or biotech industry, with a focus on vaccine and/or bacterial products required. Develop and execute regional regulatory strategies to support the development, registration, and commercialization of vaccine and bacterial products within specific regions, such as the US.
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Apply established commercial biologics Continued Process Verification (CPV) program strategies and contribute to CPV program of one or multiple biologics products. Support batch processing data collection and verification activities.
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4 or More Years of experience in the pharmaceutical industry, regulatory agency or academia, with exposure to drug development, clinical pharmacology, and/or epidemiology required. The individual assuming this role may function as a key member of the Global Product Team in collaboration with Clinical Development, Regulatory, Project Management, Biostatistics, Pharmacology, and other departments to strategically manage benefit-risk throughout the lifecycle of the drug.
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regulatory job in Morristown, NJ
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