- Insmed Incorporated (NJ)
- …each other, and for the future of science, we're in. Are you?About the Role:The Global Regulatory Lead (GRL) will be responsible for formulating and ... product development and submission activities. The GRL will serve as the global regulatory lead for documentation review prepared by other technical… more
- Eisai, Inc (Nutley, NJ)
- …management of staff.Determining timelines and budgets for program activities and report accordingly. Lead and participate in global regulatory initiatives and ... difference. If this is your profile, we want to hear from you. The Director, Global Regulatory , Growth Markets will be responsible for providing regulatory … more
- Insmed Incorporated (NJ)
- …you'll have a critical role in hands-on execution and oversight of global regulatory submission activities across assigned programs and market. Under ... operational execution, while supporting cross-functional teams to ensure alignment with global regulatory requirements and internal standards.What You'll Do:… more
- Eisai, Inc (Philadelphia, PA)
- …is responsible for the leadership and oversight of the Labeling function within Global Regulatory Services and Operations (GRSO). This position will manage ... regulations governing labeling of pharmaceutical products globally, and serves as the global regulatory labeling representative on relevant project teams to… more
- Eisai, Inc (Nutley, NJ)
- …along with a proven track record in inspection-facing roles and global regulatory compliance.Essential Functions Clinical Outsourcing Designs and executes ... business goals.Oversees Outsourcing function's adherence to ICH/ GCP guidelines, local regulatory requirements and SOPs/ SWPs on a global basis.Participates… more
- Merck & Co. (Rahway, NJ)
- …identifying process inefficiencies using operational excellence tools and ensuring alignment with global regulatory requirements (eg, FDA 21 CFR Part 820, ISO ... regulatory , company, and customer requirements. - Principal Responsibilities Lead /Support continuous improvement initiatives for design control and risk… more
- Merck & Co. (Rahway, NJ)
- …multiple large molecule programs across a variety of platformsExpert knowledge in global regulatory requirements for large molecule commercialization and BLA ... are developed by working teams supporting the product.Compile with our company's Global and regulatory requirements and execute current Good manufacturing… more
- Formation Bio (New York, NY)
- … GXP/PV/CSV regulations and guidance. Ensuring preparedness for pre-approval and routine regulatory inspections conducted by global Regulatory Health ... experience with oversight of CSV is preferred. Strong working knowledge of global regulatory requirements, including GMP, GCP, and ICH guidelines. Expertise… more
- Insmed Incorporated (NJ)
- … leader , ensuring that development programs meet scientific, quality, regulatory , and commercial standards, while ensuring execution across internal teams and ... for both clinical and commercial supply chains.Your responsibilities will include supporting global CMC regulatory strategies that align with our clinical and… more
- Insmed Incorporated (NJ)
- …supply chain readiness for both clinical and commercial needs. You will support global regulatory strategies by contributing to IND filings, BLA submissions, and ... so does every person who joins in. As a global biopharmaceutical company dedicated to transforming the lives of...diseases. Reporting to the SVP, Technical Operations, you will lead our gene therapy and large molecules pipeline from… more
- Eisai, Inc (Bethesda, OH)
- …and precision medicine. Acting as the primary data science representative to global regulatory authorities, this individual will defend strategies and influence ... specifications and directions to the clinicians/statistical programmers. Supports the regulatory review and approval of the experimental therapies. May partner… more
- Merck & Co. (Rahway, NJ)
- …potential risk, generate gap analysis and mitigation strategies In-depth knowledge of global regulatory requirements for medical devices and combination products ... leadership skills to shape the technical capabilities and strategic direction for a global , cross-modality technical team. The Director will lead a team of… more
- Merck & Co. (Rahway, NJ)
- …risk, generate gap analysis and mitigation strategies In-depth knowledge of global regulatory requirements for distribution including good distribution ... leadership skills to shape the technical capabilities and strategic direction for a global , cross-modality technical team. The Director will lead a team of… more
- Merck & Co. (Rahway, NJ)
- …potential risk, generate gap analysis and mitigation strategiesIn-depth knowledge of global regulatory requirements for distribution including good distribution ... design and execution, along with leadership skills to shape the technical capabilities lead a global , cross-modality technical team.The Associate Director will … more
- Eisai, Inc (Nutley, NJ)
- …5 years of pharmaceutical industry related experience as a Clinical Pharmacology Project Lead .A thorough understanding of global regulatory requirements on ... of Clinical Protocols to meet CDP objectives.Serves as Study Director/Clinical Pharmacology Lead and drives the execution of the study from protocol concept to… more
- Bayer (Whippany, NJ)
- …with internal Radiology capabilities, partners, thought- leader communities, vendors, regulatory authorities, and other external partners; Lead or author the ... diverse minds to make a real difference, there’s only one choice. Sr Director, Global Clinical Lead , Diagnostic Molecular Imaging The Senior Director, Global … more
- Formation Bio (New York, NY)
- …and marketing Formation Bio's assets. This role includes the lead regulatory responsibility for support of global registration and life cycle support ... treatments to patients faster and more efficiently.About the PositionThe Senior Director, Regulatory Affairs lead is responsible for developing and directing the… more
- Bayer (Whippany, NJ)
- …high engagement and collaboration across cross functional stakeholders at Local, Regional and Global level (Commercial, Finance, Regulatory , PS & Quality, etc . ... Business Partner are to: The Customer Business Partner is responsible to lead Supply Chain organization towards driving assigned products, customers and North… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …areas, supporting both clinical and commercial sites. This individual will be a key leader in the Global Quality organization and a champion for quality ... Legend Biotech is a global biotechnology company dedicated to treating, and one...such as inspection readiness, metrics implementation and review, overall regulatory compliance and implementation programs, and others as required.… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …with Market Research, Competitive Intelligence, Marketing, Medical Affairs, R&D, Finance, Regulatory , and Market Access internally across global and regional ... Marketing, Supply Chain, Finance, Market Access, Medical Affairs, and Clinical Development. Lead alignment efforts across global and regional stakeholders on… more
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