- Eisai, Inc (Nutley, NJ)
- …Claims Act, federal and state pricing-related laws and regulations, PhRMA Code and FDA regulatory guidelines.Serves as the legal representative for market access ... Member in good standing of a state bar. Strong knowledge of FDA regulatory and fraud and abuse laws and/or pharmaceutical government price reporting laws.… more
- Eisai, Inc (Nutley, NJ)
- …supplementary applications in essential. Demonstrated track record of interfacing effectively with FDA , EMA and other global regulatory agencies. Experience in ... to hear from you. Job Summary The Executive Director, Regulatory Affairs will provide leadership and direction for the...for oversight and strategic planning of the meetings with FDA , EMA, PMDA. Provide strategic support for meetings with… more
- Eisai, Inc (Nutley, NJ)
- …of Clinical Operations and Data Management preferred. Significant experience working with FDA or EMEA regulatory agencies handling responses to inquiries and ... will be working with external key opinion leaders, advisors as well as US and EU regulatory bodies in order to conduct Phase I, Phase II and Phase III studies, and… more
- Aequor (Hicksville, OH)
- …to all applicable procedures, cGMP's, company policies, and all other quality or regulatory requirements (OSHA, DEA, FDA , EMEA, ANVISA, HS&E, etc.). Ensures all ... a safe, effective manner, and in compliance with the appropriate industry and regulatory ( FDA , DEA, OSHA) standards, and Departmental, Plant, and Corporate… more
- Aequor (Hicksville, OH)
- …to all applicable procedures, cGMP's, company policies, and all other quality or regulatory requirements (OSHA, DEA, FDA , EMEA, ANVISA, HS&E, etc.). Ensures all ... a safe, effective manner, and in compliance with the appropriate industry and regulatory ( FDA , DEA, OSHA) standards, and Departmental, Plant, and Corporate… more
- Aequor (Hicksville, OH)
- …to all applicable procedures, cGMP's, company policies, and all other quality or regulatory requirements (OSHA, DEA, FDA , EMEA, ANVISA, HS&E, etc.). Ensures all ... a safe, effective manner, and in compliance with the appropriate industry and regulatory ( FDA , DEA, OSHA) standards, and Departmental, Plant, and Corporate… more
- Merck & Co. (Rahway, NJ)
- …for FDA e-data mailboxes (CBER/CDER), attendance at meetings with regulatory agencies ( FDA , EMA, PMDA),Guiding project teams preparing submission ... art scientific methodologies and tools to enable the discovery, development, regulatory approval, manufacturing, and marketing of medical drugs and vaccines for… more
- Merck & Co. (Rahway, NJ)
- …phase drug product manufacturing processes to GMP production facilities.Experience authoring regulatory filings, and demonstrated working knowledge of FDA , ICH, ... packaging, compatibility characterization for processing and administration, and supporting regulatory filings.Collaborate with key stakeholders across the organizations (Research… more
- Merck & Co. (Rahway, NJ)
- …ideas, but also have pragmatic approach to development options, technology selection and regulatory postureDemonstrated working knowledge of FDA , ICH, and other ... formulation, manufacturing process, and primary packaging to enable phase appropriate regulatory filings for large molecule sterile products. -These sterile products… more
- Repligen (Waltham, MA)
- …audits. Experience with eQMS systems or digital audit tools Familiarity with regulatory standards ( FDA , GMP, etc.). Excellent communication, negotiation, and ... supporting root cause investigations, and ensuring Repligen's supplier network meets regulatory and quality standards. This role is based in Waltham, MA,… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …Investigations, Corrections, and QMS records.Build the Site Readiness of MES for FDA and/or Other Regulatory Audits / Inspections.This individual is responsible ... for the training of Manufacturing Excellence on MES utilization and ensuring that Manufacturing Excellence properly assesses updates and impact.Key Relationships: establish key stakeholder relationships with internal and external stakeholders. Ability to… more
- Merck & Co. (Rahway, NJ)
- …Rahway (RY) NJ Campus. - This role ensures HVAC systems comply with regulatory standards (eg, FDA , cGMP), maintain optimal environmental conditions for product ... operational strategies that ensure compliance with GxP (as applicable) and other regulatory requirements.Lead the operation of the site BAS and HVAC control systems.… more
- Twist BioScience (South San Francisco, CA)
- …platforms (eg, AWS, Azure, GCP) and DevOps practices.Direct experience participating in regulatory audits (eg, FDA inspections) specifically related to custom ... of our proprietary MES technologies will ensure strict adherence to regulatory requirements, optimize complex biological manufacturing processes, and align with our… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …performance, and develop talent. Ability to create an engaged workforce.GMP Compliance & Regulatory Knowledge: Deep understanding of FDA , EMA, and other global ... controls, and maintain permanent inspection readiness and actively support regulatory inspections.Lead facility operating review meetings and sponsor various… more
- Leica Biosystems (Miami, FL)
- …or PhD in a scientific or engineering discipline. In-depth working knowledge of FDA and EU regulatory requirements for Companion Diagnostics (CDx) devices. ... about the Danaher Business System which makes everything possible.The Senior Principal, Regulatory Affairs is responsible for regulatory strategy development and… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …within the organization. From healthcare provider interactions and developing and implementing regulatory strategies with the FDA to providing medical education ... About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one...in compliance with local and federal regulations (21 CFR FDA Post-Marketing), global/local SOPs, and other governing standards Maintains… more
- Merck & Co. (Rahway, NJ)
- …Communication, Cross-Cultural Awareness, Data Management, Employee Training Programs, FDA Regulations, Management Process, Pharmacovigilance, Policy Implementation, ... experience and skills: Min. 5-10 years of experience with Pharmaceutical Regulatory Affairs Operations with Labeling Process and/or Digital Enablement experience… more
- Merck & Co. (Rahway, NJ)
- …US FDA and global health authorities to advocate advanced regulatory strategies for novel medicines.Contributing to the continuous improvement of the operating ... Job DescriptionPosition Description:The Vice President, Regulatory Affairs, General Medicine, will contribute to the mission and vision of the Global Regulatory … more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …and Companion Diagnostic productsProven experience with Health Authority Inspections, (eg, FDA , HPFB, MHRA and other European regulatory agenciesInternational ... audits effectively. Ensure the internal systems auditing program fulfills regulatory requirements performs audits, identifies compliance issues and trends, reviews… more
- Formation Bio (New York, NY)
- … Regulatory Compliance & Submissions Ensure all CMC activities comply with global regulatory expectations (eg, FDA , EMA, ICH); author and review regulatory ... development through commercialization. You will oversee internal and external teams, ensure regulatory compliance, and play a key role in scaling our biologics… more
