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We structure ourselves to deliver scientific expertise to our clients; collaborating closely with them to support the development of medicinal products through the drug development process and onto market.
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Responsible for managing assigned factories in all aspects of quality and compliance including but not limited to: design, development, production, and end-customer quality, Health, Safety, and Environmental Compliance, Regulatory Compliance, and Restricted Substances compliance.
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We are seeking an experienced Director, Regulatory Strategy who will be responsible for leading the overall regulatory strategy and direction of drug development opportunities and coordinates team tactics, priorities, resources to systematically build and execute complete development plans that align with client business strategies.
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Strong industry experience, technology-enabled services, and a data-driven approach to drug development make MMS a valuable CRO partner, creating compelling submissions that meet rigorous regulatory standards.
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MMS is an innovative, data-focused CRO that supports the pharmaceutical, biotech, including clinical trial transparency,and medical device industries with a proven, scientific approach to complex trial data and regulatory submission challenges.
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Understands the life sciences industry (e.g., CROs, pharma/biotech, medical device), scientific & clinical data/terminology, and the drug development process. Knowledge of and experience in selling biometrics, regulatory submissions, and regulatory operations will be a distinct advantage.
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Understanding of scientific principles and regulatory/quality systems relevant to drug development. Acceptable and independent skills in the area of regulatory affairs such as understanding broad concepts within labeling and implications across the organization and globally; proactively identify issues; offers creative solutions and strategies, including risk mitigation strategies.
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Professional Knowledge: Thorough understanding of diagnostic technologies, global regulatory frameworks, and biomarker applications in drug development. Develop and enforce operational standards for biomarker management, vendor relations, and internal processes to ensure program quality, efficiency, and regulatory compliance.
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ZS is looking for a Decision Analytics Consultant in the ZS Supply Chain and Manufacturing practice with an experience in pharmaceutical drug development and tech transfer. 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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Provide operational coordination and management to drive strategies and activities for early and late phase drug development candidates within the team to support overall CMC development plan.
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Extensive oncology experience, including proficiency in target/disease biology, preclinical, and clinical development. Engage with external diagnostic providers and global regulatory agencies to establish CDx filing pathways and compliance strategies.
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Have a passion around the impact HEOR has in the drug development process. Report, publish and disseminate HEOR data and study results in compliance with company, industry and regulatory requirements.
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In this vital role the Senior Counsel -R&D Regulatory will be responsible for legal support of Amgen’s Global Development organization, as well as Global Regulatory Affairs, Patient Safety, Medical Affairs, R&D Quality and Compliance, Precision Medicine, Drug Delivery, and other R&D functions.
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Provide regulatory guidance to drug development teams, merging scientific principles and FDA law and regulations for development of marketing materials. Job Description About the role: Join Takeda as a Senior Manager, US Medical Ad/Promo Regulatory Review where you will serve as an internal expert on FDA regulations, guidance, and enforcement trends governing the promotion of prescription drug and biologic products.
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It is the division's leader in sterile product and process development, responsible for late-stage commercialization activities including process scale up, technology transfer to internal and external sites, process validation, authoring of regulatory submissions and support of significant manufacturing investigations.
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