- Cipla (Hauppauge, NY)
- …and other packaging materials. Ensure that the artwork complies with all relevant regulatory guidelines (eg, FDA , EMA) and industry standards, including proper ... Outlook, PowerPoint) and other relevant inventory/warehouse management software. Familiarity with FDA labeling requirements and other regulatory standards for… 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 ... Operations, Commercial, NNI IT and Telephony, Medical Information, Product Safety, Regulatory , Quality , Legal, Privacy and Finance. External relationships… more
- Merck & Co. (Rahway, NJ)
- …closely with team members and partner groups including formulators, engineers, Quality , Safety, and Facilities management to drive overall success and performance ... PAS-X is preferable.GMP: Follow established inspection batch records, protocols and quality standards to ensure compliance with industry regulations.- Able to report… more
- Merck & Co. (Rahway, NJ)
- …will ensure products and processes are developed in accordance with applicable regulatory , quality , company, and customer requirements.-This position will lead ... strategy.Knowledge of US and global medical device and healthcare regulations, including FDA combination products cGMP, Quality System Regulation, FDA … more
- Merck & Co. (Rahway, NJ)
- …Content Management Systems (CMS), Cross-Cultural Awareness, Data Management, Data Quality Assessments, Documentation Review, Employee Training Programs, FDA ... Source Management Business Operations Lead is expected to understand the end-to-end regulatory submission process. The main focus will be on document production… more
- Eisai, Inc (Boston, MA)
- …provides submission leadership by managing the operational aspects of global regulatory submissions to produce high- quality , time-sensitive deliverables in ... regulatory submission final deliverables, ensuring compliance with applicable regulatory agency regulations, guidelines, and specifications (eg, FDA , EMA,… more
- Lupin Pharmaceuticals (Coral Springs, FL)
- …field.Proven leadership abilities, strong knowledge of regulatory frameworks (eg, FDA ), GCP guidelines, and quality management systems.Preferred but Not ... success etc.Provide expert recommendations based on scientific and medical analysis. Regulatory Compliance: Ensure adherence to FDA guidelines for 505(b)(2)… more
- Merck & Co. (North Wales, PA)
- …PreNDA-and PreBLA-meeting preparation, study data standards plan, preparing questions for FDA edata-mailboxes (CBER/CDER), attendance at meetings with regulatory ... Job Description Responsibilities: Provide oversight and quality management of submission data standard deliverables for world-wide regulatory application… 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...find better and more innovative ways to improve their quality of life. We're changing lives for a living.… more
- Sanofi (Swiftwater, PA)
- …year) which are distributed throughout the world. This position guarantees the Quality and Regulatory compliance of products developed, manufactured and ... distributed by the site in accordance with Regulatory requirements and Global Quality policies and...practical expertise with cGMP requirements including WHO, ICH, US FDA , Canadian BGTD, Australian TGA, EU GMP, Japanese ;… more
