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The Associate Director, US Regulatory Affairs (RA) serves as the regulatory lead on relative Review Committees (RCs), for products in the Rare Disease, Rare Blood Disorder and Neurology portfolio.
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This position independently manages relationships with internal (CSPV, Regulatory, Clinical, Medical Affairs, HEOR and other stakeholders to ensure expectations are clearly defined and met across participating teams) and external stakeholders.
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Hnliche Stellen (5) Head of Global Market Access, Specialty Care locations 2 Standorte time type Vollzeit posted on Vor mehr als 30 Tagen ausgeschrieben Corporate Counsel, US Market Access Legal locations 2 Standorte time type Vollzeit posted on Vor mehr als 30 Tagen ausgeschrieben Associate Director, US Advertising and Promotion, Global Regulatory Affairs locations 2 Standorte time type Vollzeit posted on Vor mehr als 30 Tagen ausgeschrieben.
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The Senior Associate, Regulatory Affairs is responsible for supporting applications under pre and post approval conditions. 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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Represents Global Regulatory Affairs (US RA AdPromo) as a member of cross-functional brand and portfolio team review committees (RC), providing regulatory input into the review and approval of US advertising, promotion, disease-state, market access, and press materials.
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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.
ExpandApply NowActive JobUpdated 7 days ago - UpvoteDownvoteShare Job
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Proclinical is seeking an Associate Director, US Regulatory Affairs, Advertising & Promotion for a large global pharmaceutical company with locations in New Jersey and Massachusetts.
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Ensures cross-functional execution of the pediatric segment strategy with US partners, including sales, brand marketing, customer operations, market access, medical affairs, policy, communications, Health Economics, regulatory, legal, and compliance.
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The Associate Director/Director, Regulatory Affairs - GDP, provides essential support to the Senior Director in overseeing regulatory activities related to Quality of Life (QOL) initiatives on a regional and/or global scale.
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Requires a broad understanding of the pharmaceutical industry, generic industry, commercial channels, intellectual property and Regulatory Affairs. We are seeking a talented and motivated Associate Director, Portfolio to join our team.
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4 or More Years of direct regulatory affairs experience, including US labeling experience required. Based on timelines or resources, may assist another Global Labeling Lead by managing labeling development or approval for either the US or EU. Preparation of updated Core Data Sheets, and EU and US Documentation: Independently manages, prepares and implements regulatory documents (e.g., USPI, annotated labeling, medication guides, EU SmPC, PIL, CCDS.
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The Senior Associate, Regulatory Operations/CMC reports into the Manager/ Director, Regulatory Affairs and is based in Morristown, New Jersey. Minimum of 4years in the pharmaceutical industry with 3 of those years in regulatory affairs.
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CMC Regulatory Affairs. Regulatory Affairs general practices for generic drugs, FDA guidance's. In this role, you will be responsible for assisting the Senior Manager of Regulatory Affairs and other team members in various Regulatory-related tasks mentioned below.
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The Associate Director RA serves as the regulatory lead on Review Committees (RCs). This individual is expected to competently and confidently represent Regulatory Affairs as a key member of cross-functional RC teams for assigned, as well as for all verbal and written communications with OPDP/APLB reviewers.
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Ensure cross-functional execution of health system segment strategy with US key stakeholders, including sales, brand marketing, customer operations, market access, medical affairs, policy, communications, Health Economics, regulatory, legal, and compliance.
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regulatory affairs associate jobs in Basking Ridge, NJ
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