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Director of Risk Management & Regulatory Affairs ( Patient Safety Officer / Privacy Officer ) The Director of Risk Management and Regulatory Affairs (Patient Safety Officer/Privacy Officer) serves as an accessible resource to the hospital and community on risk management and regulatory issues.
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The Sr Manager, GCP Quality Assurance coordinates GCP Compliance activities with Clinical Operations, Regulatory Affairs, Clinical Supply & Logistics, Sample Management and Pharmacovigilance as well as varied vendors supporting Clinical Studies.
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Collaborate with internal teams (e.g., marketing, product development, regulatory affairs) to ensure alignment of business development strategies with company goals. Maintain a deep understanding of industry trends, competitive landscape, and regulatory changes to inform strategic decisions.
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Coordination with internal and external stakeholders, including Process Development, External Manufacturing, Supply Chain, Quality Assurance, Regulatory Affairs, Clinical Supply, Clinical Operations, and Program management.
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Join our compassionate and dedicated team and make a difference in the lives of our members at the Health Plan. The Director of Regulatory Affairs will be responsible for The MLTC-Director of Contracts/Compliance will be responsible for directing, delivering, evaluating, and coordinating activities of the Regulatory Affairs Department.
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We are seeking a highly motivated and experienced Associate Director Regulatory Affairs with expertise in hematology / oncology to join our Drug Discovery and Early Development team. Experience managing regulatory affairs in Hematology/Oncology is required.
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G&L are working in partnership with this client to provide a number of experienced regulatory affairs professionals with expertise in small molecule CMC. We are looking for proactive, solutions-oriented talent with great communication skills to join this progressive team with an immediate start.
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Schrödinger seeks an Associate Director of Regulatory Affairs to join our New York early clinical development team. This hire will report to the Director of Regulatory Affairs and will play an essential role in regulatory activities to support activities of global oncology trials in early clinical development.
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Demonstrated experience working with routinely collected data (claim databases, electronic medical (health) records, registries), and various structured and possibly unstructured data sources in the healthcare sector within pharmaceutical companies’ settings in commercial market access, medical affairs, scientific affairs and/or R&D environment.
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As part of the Regulatory Affairs CMC team, you will report to the Executive Director and Head, CMC Regulatory Affairs – Pharmaceuticals. How you will contribute: Leads the Early Development Pharmaceuticals GRA CMC regulatory team in the development and implementation of global CMC regulatory strategies during development ,commercialization and post approval LCM stages Combines knowledge of scientific, regulatory and business issues to ensure the regulatory filings are of high quality and right first time.
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Leads the Early Development Pharmaceuticals GRA CMC regulatory team in the development and implementation of global CMC regulatory strategies during development ,commercialization and post approval LCM stages.
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Drives ongoing clinical trial execution at study sites in collaboration with Clinical Research and Development, Clinical Operations, Regulatory Affairs and Program Management including, but not limited to, site identification, evaluation and training, recruitment, and participation at Investigator’s Meetings.
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Demonstrated understanding of the legal and regulatory guidelines (e.g., PhRMA, ACCME, Sunshine Act, etc.) The Manager/Sr. Manager will have additional operational, project management responsibilities in support of the Scientific Affairs Team within Medical Affairs (e.g., budget tracking and management, dashboard creation and maintenance, metrics, and reporting.
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Assist EVP and Senior Legal Counsel in ensuring organizational compliance with applicable laws and regulations, such as lobbying, regulatory and public policy matters, and laws relating to charitable solicitations in New York State and nationally.
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The Vice President for Student Affairs oversees policies and procedures related to student conduct and discipline, ensures that college policies and practices provide fair and equitable treatment of all students, and that the programs and services in the Division of Student Affairs, including Athletics, comply with federal and state laws as well as the regulations, policies and guidelines of CUNY and other regulatory and accrediting bodies.
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regulatory affairs jobs in New York, NY
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