- 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
- 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
- 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)
- …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)
- …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)
- …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)
- …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
- 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
- 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
- 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 ... momentum, and an inspiring mission to achieve new milestones in global healthcare . The Biologics and Biopharmaceutics team is responsible for the research and… 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
- Repligen (Waltham, MA)
- …audits. Experience with eQMS systems or digital audit tools Familiarity with regulatory standards ( FDA , GMP, etc.). Excellent communication, negotiation, and ... root cause investigations, and ensuring Repligen's supplier network meets regulatory and quality standards. This role is based in...learning curves and the opportunity to contribute to the healthcare of patients worldwide. All of this with an… more
- Lundbeck (Fresno, CA)
- …Environment/Compliance - Ability to apply knowledge of pharmaceutical and regulatory environment, including accountability and adherence to Lundbeck policies and ... procedures and FDA regulations regarding the promotion of pharmaceutical and medical...years pharmaceutical, biopharmaceutical, biologics, medical device sales or related healthcare sales experience Must demonstrate the intellectual capacity to… 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...for all our job applicants. We're not your typical healthcare company. In a modern world of quick fixes,… 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
- Eisai, Inc (Nutley, NJ)
- At Eisai, satisfying unmet medical needs and increasing the benefits healthcare provides to patients, their families, and caregivers is Eisai's human health care ... clinical information to customers and key stakeholders consistent with the FDA -approved indication. Additionally, the Senior NAS will be responsible for ensuring… 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
