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Interface effectively with all other BMS internal stakeholders: Global Medical Affairs functions and other departments, including Commercial, Clinical Research and Development, Regulatory Affairs, Managed Care, Pharmacovigilance, Market Access, Statistics, Translational Research/Development, Project Leadership, etc.
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Collaborating with internal and external Customers and Service Providers, including but not limited to Clinical Research and Development, Global Study Management and Monitoring (GSMM), Project Management, Affiliates, Medical Affairs (MA), Regulatory, CMC, QA, Packaging Vendors, CRO’s, IRT Organizations, and Global Clinical Supply Chain Functional Operations to ensure all needs are met.
$74 - $78 an hourExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
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Strong partnerships and open communications with Clinical Development, Clinical Operations, Data Management, Clinical Pharmacology, Toxicology, Regulatory Affairs, Medical Affairs, Quality Assurance, Biostatistics, Legal, Sales and Marketing, service providers, vendors, contract research organizations (CROs) and external partners required to ensure they are informed of evolving safety issues and strategies.
$250,000 - $315,000 a yearFull-timeExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
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Advanced life science degree or certification in Regulatory Affairs Sciences preferred. Experience and solid knowledge of Pharmacovigilance specificallyProficiency in one or more of these additional areas is a plus: CMC/Mfg., Clinical development and trial execution, Regulatory, Real-World Data and Real-World Evidence, Cell and Gene Therapy, Medical Device, IVD/CDxExperienced in understanding and interpreting regulatory guidelines and documents.
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With 5 years in the industry with at least 4+ years of US Medical Device Regulatory Affairs experience. Leadership responsibility for global regulatory strategy to support the development of biomarkers, companion diagnostic tests, digital health and other devices to enhance the value of our pharmaceutical products across therapeutic areas.
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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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Our Medical Affairs function serves as a key strategic partner with commercial, regulatory, clinical, and market access on therapeutic solutions to support patients’ needs. Within the Global Medical Affairs Immunology team, we are proud to support Sanofi’s unrelenting commitment to scientific exploration and to work on a first-in-class treatment and robust pipeline of potential new medicines for chronic dermatologic, respiratory, rheumatologic, and gastrointestinal diseases.
$250Full-timeExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
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Reports To: Director, Regulatory Affairs Advertisement, Promotion and Labeling. Bachelor’s degree and 5+ years of relevant pharmaceutical industry experience with 4+ years of relevant Regulatory Affairs advertising, promotion and labeling experience.
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Proven and relevant regulatory affairs experience in pharmaceutical, vaccine, or biological products; or related fields. Demonstrate an understanding of regulatory affairs and apply this understanding to the benefit of the company to ensure approval and Product supply continuity.
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Lead development and execution of global product and project regulatory strategy(ies) by ensuring robust assessment of CMC changes, identification of global regulatory requirements and critical evaluation of supporting documentation to confirm acceptability and identification of potential risks.
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Knowledge of medical device industry, regulatory affairs, as well as discipline throughout the product lifecycle including Development, Commercialization, and Operations. Ability to understand and apply business drivers outside of Regulatory Affairs.
$35 - $45 an hourExpandApply NowActive JobUpdated 2 days ago - UpvoteDownvoteShare Job
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The Senior Manager, Regulatory Affairs - GDP, plays a pivotal role in supporting the Executive Director in overseeing regulatory activities related to antiviral initiatives. 5 years of experience in regulatory affairs within the pharmaceutical or biotech industry, with a focus on antiviral products preferred.
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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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CMC regulatory affairs, or a related field within the pharmaceutical or medical device industry. Specific certifications related to drug-device combination products or regulatory affairs (e.g., Regulatory Affairs Certification) could be advantageous.
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Prepares legal documents such as contracts, correspondence (e.g., to regulatory agencies), both independently and for review, approval, and use by Legal Affairs management. Acts as legal advisor for assigned corporate business and functional areas of the Daiichi Sankyo Oncology Business Unit and US Oncology Business Division of the Company (including, for example, Market Access, Sales, Marketing, Medical Affairs) as well as DSI employees performing Global roles in the United States (such as Global Marketing, Global Medical Affairs.
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regulatory affairs jobs in Basking Ridge, NJ
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