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Clinical Excellence: Oversee the development of digital solutions for clinical trials, patient monitoring, and healthcare analytics, ensuring adherence to regulatory standards and best practices.
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Works closely with the Regulatory Affairs labeling group regarding package insert changes to assess and determine the impact of proposed labeling changes on product promotion. Broad knowledge of the pharmaceutical industry Regulatory Affairs discipline for prescription drugs.
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Represent Regulatory CMC on cross-functional development/commercial teams and Regulatory Affairs teams. Responsibilities: Participate in the development of the CMC regulatory strategy for small molecules, biologics and cell therapy submissions.
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The New Jersey Director of State Affairs serves as the principal staff for state government affairs and chief lobbyist in NJ, representing the Alzheimer's Association before NJ's legislature, governor, relevant state agencies, community stakeholders and coalitions, and on statewide task forces and work groups.
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At minimum 10 years' experience in the pharmaceutical industry in Biologics/Research & Development/Regulatory Affairs. Ensure strategic regional regulatory input which is in consideration of the commercial strategy and is provided into global regulatory teams and that the Regional Regulatory TA Team supports the Global Regulatory Affairs (GRA) vision of excellence, good scientific practice, integrity and compliance with regulatory standards.
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This position reports to VP, CDMA with a dotted line reporting relationship to the CSO. The Senior Director CDMA will interact with internal colleagues in Research and Development (Clinical Development & Medical Affairs, Strategic Operations, Evidence Generation & Data Sciences, Regulatory Affairs, Pharmacovigilance) Strategy/Portfolio Management,Commercial and Operations functions.
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He/she manages the writing of response to CMC questions from Health Authorities with support from Quality, Global Regulatory Affairs (GRA), technical experts or CMOs. He/she defines and manages the compilation of the documentation, required for the authoring by reaching out to appropriate internal/external functions such as quality, manufacturing, Global Regulatory Affairs (GRA), technical experts from global locations or contract manufacturing organizations (CMOs), or alliance partners.
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Participate in the development of the CMC regulatory strategy for small molecules, biologics and cell therapy submissions. BS/BA degree in Scientific Discipline (Masters or higher preferred) with 5-7 years in the pharmaceutical industry, preferably with 1-3 years CMC regulatory experience.
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The Manager, Regulatory Affairs – Regulatory Project Management (RPM) provides planning and coordination supports for global and US regulatory activities. Plan, coordinate, and review US regulatory submissions in collaboration with USRL, Regulatory Operations (RO), and other key stakeholders (e.g. Protocol Amendments, Form 1572s, Information Amendments, Meeting Requests/Background Materials, DSUR, IND/NDA/BLA annual reports, BTD request etc.
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Experience with CMC regulatory documents (IND/CTAs, BLA/NDAs, MAAs, responses, variations and briefing documents) Experience in developing CMC regulatory strategy. These submissions include health authority briefing packages, IND/CTA, BLA/NDA and MAA regulatory filings.
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5-7 years in the pharmaceutical industry, preferably with 1-3 years CMC regulatory experience. Responsible for the global regulatory evaluation of CMC change controls with supervision. 5-7 years in the pharmaceutical industry, preferably with 1-3 years CMC regulatory experience.
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For base business hybrid responsibility, key constellation includes local brands teams (including science hub), respective category brand team, respective category claims lead and regional scientific affairs and activation teams.
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Solid experience in medical affairs, clinical and/or translational research in hematology or oncology Preferably 5+ years of medical and/or research experience, preferable with focus on oncology or hematology (Experience working in Myeloid malignancies.
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The Director of External Affairs plays a pivotal role in advancing the mission of the Morris Museum through fundraising, special events, membership management, and community relations. Minimum of 5-7 years of progressively responsible experience in fundraising or external affairs, preferably in a museum or cultural institution.
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This position reports to the VP, Global Regulatory Affairs. Regulatory Affairs - Bridgewater, NJ - Full Time Summary. Actively contribute to the development of regulatory strategies for investigational products in Investigational New Drug (IND)/ Clinical Trial Applications (CTA), Biologics Licensing Application (BLAs)/ Marketing Authorization Application (MAA), through evaluating scientific merits of Chemistry, Manufacturing and Control (CMC) and nonclinical study data package.
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Title: regulatory affairs Company: Sanofi in Basking Ridge, NJ
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