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In certain situations, may serve as chair of Core Medical Team, at the discretion of the Executive Director Represent NNI Medical Affairs on Global Core Medical Team (CMT) Collaborate with HEOR to provide clinical input on HEOR projects and authorship on abstracts, posters, and manuscripts, when requested Serve on Local Labeling Committee (LLC) and provide medical input to Regulatory Affairs Physical Requirements 20-30% overnight travel required.
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The Team Lead for Authoring Support Group will be part of the Global Regulatory Operations group and will develop and manage the authoring support group within Regulatory Affairs (RA) to ensure timely and high-quality document delivery to the Regulatory Publishing Group.
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Fosters strong relationships with internal teams, including Sales, Commercial Excellence, R&D, Medical Affairs, Regulatory Affairs, Market Access, Legal and Compliance to ensure alignment in product development, launch strategies, and lifecycle management.
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Deloitte Risk and Financial Advisory's Financial Services Industry (FSI) Risk, Data and Regulatory professionals help organizations identify the regulatory changes impacting their business and implement effective and efficient processes to manage regulatory, capital, liquidity and interest rate risks, respond to evolving regulatory environments and implement programs, measures, and tools to help clients with a specific focus on risk, data, and regulatory processes.
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In this role, the CMC Regulatory Manager will serve as the primary interface between Global Regulatory Sciences (GRS) & Global Product Supply (GPS) The GRS-CMC senior manager will assess Manufacturing Change Controls for global impact & guide technical teams on practical aspects of global change management.
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The Associate Director, Regulatory Operations role is accountable for managing regulatory submission related activities, providing business ownership and management of IT systems within the scope of Regulatory Affairs/Operations.
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Safe and timely execution of Phase I studies; close collaboration with internal and external clinical study support staff and scientists (including discovery research, biostatistics, drug metabolism, modeling and simulation, regulatory affairs, and global clinical trials operations.
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Ensure the local HSE management system is effectively designed, implemented, and controlled and meets Firmenich standards, ISO standards, and all relevant regulatory requirements. Thorough knowledge of OSHA regulations and experience working with regulatory agencies.
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ERM delivers a wide range of climate change services including decarbonization strategy development, creation of Scope 1, 2, and 3 carbon inventories, Task Force on Climate-related Financial Disclosure (TCFD) analysis and reporting, strategy development, policy and regulatory analysis, target setting, and benchmarking.
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Develop strategy and deploy NA/GF Innovative Medicines HCC policies and procedures in support of government, privacy, legal and company HCC standards, and procedures in partnership with Law Department, HCC, Regulatory, Advertising, & Promotion (RAP) and other functions as needed.
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Advanced understanding of pharmaceutical development and CMC regulatory affairs including regulatory guidelines, federal regulations and legal considerations. The Director, Regulatory Affairs integrates and applies knowledge of US regulatory guidelines and federal regulations governing pharmaceutical drug development to all aspects of Our Client’s ’s drug development programs, policies and procedures; ensuring a compliant state of regulatory commitment.
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Familiarity with genomics assay qualification/validation guidelines and guidance (FDA, CAP, CLIA, ACMG, NYSDOH, global regulatory requirements for assay development). Knowledge of clinical sample analysis regulatory and quality frameworks and guidance in the lab and at vendors (such as GCP, CLIA, CAP, and NYDOH.
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In addition to keeping abreast of regulatory, economic, and financial market trends, the Portfolio Manager will actively participate in community functions, and continue to expand their knowledge in all Private Banking and wealth management services including credit, risk management, investments, financial planning, fiduciary, and insurance as well as real estate, retirement, and tax planning.
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Kelly® Science & Clinical is seeking a Regulatory Affairs Associate for 1 year contract position (with possibility of extension) position at a premier client in Skillman, NJ. If you’re passionate about bringing the latest scientific discoveries to life and are ready to take the next step in your career, trust The Experts at Hiring Experts.
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Knowledge of key concepts including unit operations, processes, quality by design (QbD), tech transfer, process validation, quality attributes, and regulatory milestones across pharma development.
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regulatory affairs jobs Title: general Company: Drm in Princeton, NJ
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