- 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
- Eisai, Inc (Nutley, NJ)
- …supplementary applications in essential. Demonstrated track record of interfacing effectively with FDA , EMA and other global regulatory agencies. Experience in ... At Eisai, satisfying unmet medical needs and increasing the benefits healthcare provides to patients, their families, and caregivers is Eisai's human health care… 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
- Novo Nordisk Inc. (Plainsboro, NJ)
- …the organization. From healthcare provider interactions and developing and implementing regulatory strategies with the FDA to providing medical education and ... 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)
- …assembly processes.Extensive knowledge of US and global medical device and healthcare regulations, including FDA combination products cGMP, Quality System ... in the design, manufacturing, verification, validation and associated quality and regulatory aspects of combination products.The incumbent must be able to lead… more
- Merck & Co. (Rahway, NJ)
- …or design controls areaKnowledge of US and global medical device and healthcare regulations, including FDA combination products cGMP, Quality System Regulation, ... from early design concept definition through commercialization to support regulatory filing, product launch, and post-market surveillance.This position will interact… 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)
- …ideas, but also have pragmatic approach to development options, technology selection and regulatory postureDemonstrated working knowledge of FDA , ICH, and other ... momentum, and an inspiring mission to achieve new milestones in global healthcare . The Biologics and Biopharmaceutics team is responsible for the research and… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …the organization. From healthcare provider interactions and developing and implementing regulatory strategies with the FDA to providing medical education and ... About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one...of local/federal laws and applicable regulations applicable (21 CFR FDA Post-Marketing), global/local SOPs, and other governing standards (ie.… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Companion Diagnostic products preferredProven experience with Health Authority Inspections, (eg, FDA , HPFB, MHRA and other European regulatory agencies) ... File (eTMF) and other pivotal documents to be submitted to the regulatory authorities for application Qualifications: Successful candidates will be able to meet… more
- 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 ... Eisai, satisfying unmet medical needs and increasing the benefits healthcare provides to patients, their families, and caregivers is...good standing of a state bar. Strong knowledge of FDA regulatory and fraud and abuse laws… 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
- Eisai, Inc (Boston, MA)
- …systems).Experience working with pharmaceutical manufacturer compliance & regulatory requirements.Experience networking, establishing, and maintaining strong ... At Eisai, satisfying unmet medical needs and increasing the benefits healthcare provides to patients, their families, and caregivers is Eisai's human health care… 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
- Lundbeck (Fort Wayne, IN)
- … regulatory environment, including Lundbeck policies and procedures and FDA regulations regarding the promotion of pharmaceutical and medical products. Ability ... to apply knowledge of overall healthcare economy and industry practices. Accountability and adherence to corporate, FDA , and PDMA guidelines. REQUIRED EDUCATION,… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …or enforcement litigation are preferred Additional experience within the healthcare /pharmaceutical industry (including experience with FDA , advertising and ... ready to realize your potential? The Position Provide legal counsel to global healthcare company on relevant issues involving application of US law, regulations, and… more
- Merck & Co. (Rahway, NJ)
- …Provide technical oversight of cell culture process development, process characterization and regulatory filing activities to ensure a smooth and clear path to ... control strategies, process comparability reports, Process performance qualification, and/or regulatory submissions.CMC RA: Experience supporting/writing regulatory filings… more
- BioAgilytix (Durham, NC)
- …that boost lab productivity and keep BioAgilytix ahead of regulatory requirements.Key ResponsibilitiesData Governance & Quality Standards:Develop a foundational data ... build quality assurance processes, and monitor data integrity to meet regulatory requirements, including HIPAA, GxP, GDPR, and FIRPA.Design data quality KPIs… more
- AUROBINDO (Durham, NC)
- …with expertise in manufacturing, R&D, Quality Assurance and Quality control and regulatory affairs. In addition to several formulations under manufacture, we have a ... robust pipeline of products. Aurolife's aim is to provide healthcare at economical prices to make this a healthier...expedite receipt of incoming product through customs and the FDA . The position is also required to work closely… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …the organization. From healthcare provider interactions and developing and implementing regulatory strategies with the FDA to providing medical education and ... About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one...equivalent role required 3 years of experience in a healthcare system preferred Direct experience in therapeutic area (Hemostasis)… more
