- Daiichi Sankyo, Inc. (Bernards, NJ)
- …more years with focus on pharmaceutical regulatory affairs, incl. familiarity with regulatory compliance frameworks (eg, ICH, FDA , EMA) (Required)2 or ... on a consistent basis and identifying areas of potential non- compliance or operational risks.Responsibilities:Maintain regulatory procedural documentation, in… more
- Merck & Co. (Rahway, NJ)
- …Programs, FDA Regulations, Management Process, Pharmacovigilance, Policy Implementation, Regulatory Affairs Compliance , Regulatory Compliance , ... 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)
- …and effective implementation and oversight model to maintain best in industry regulatory compliance .The Vice President Regulatory Affairs, General Medicine ... US FDA and global health authorities to advocate advanced regulatory strategies for novel medicines.Contributing to the continuous improvement of the operating… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …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
- 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...compliance with local and federal regulations (21 CFR FDA Post-Marketing), global/local SOPs, and other governing standards Maintains… more
- Merck & Co. (Rahway, NJ)
- …Plant Maintenance, Preventative Maintenance Programs, Process Control Systems, Project Management, Regulatory Compliance , Regulatory Requirements {+ 3 ... Rahway (RY) NJ Campus. - This role ensures HVAC systems comply with regulatory standards (eg, FDA , cGMP), maintain optimal environmental conditions for product… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …execute audits effectively. Ensure the internal systems auditing program fulfills regulatory requirements performs audits, identifies compliance issues and ... audits, remediations implemented and CAPAs pending.Support Risk Mitigation programs to ensure compliance to regulatory guidelinesEnsure up to date audit CAPA… more
- Merck & Co. (Rahway, NJ)
- …Process Improvements, Project Information Management, Project Management, Project Planning, Regulatory Compliance , SAS Macros, Social Collaboration, Software ... for FDA e-data mailboxes (CBER/CDER), attendance at meetings with regulatory agencies ( FDA , EMA, PMDA),Guiding project teams preparing submission… more
- Merck & Co. (Rahway, NJ)
- …controls approach within Device Development and with external suppliers.Understand and apply regulatory / compliance requirements relative to design controls and ... from early design concept definition through commercialization to support regulatory filing, product launch, and post-market surveillance.This position will interact… more
- Lovelace Biomedical Research Institute (Albuquerque, NM)
- … Oversight: Uphold the highest standards of quality and compliance with all regulatory bodies to include the USDA, FDA , CDC, and other similar governmental ... Will utilize prior industry experience to optimize resource allocation, ensure regulatory compliance , and uphold rigorous scientific standards. Understanding… more
- Merck & Co. (Rahway, NJ)
- …in the design, manufacturing, verification, validation and associated quality and regulatory aspects of combination products.The incumbent must be able to lead ... full integration of the device development activities with the clinical, regulatory , formulation, commercial and other key company functions.Lead the Device… 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
- 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...highest quality to patients. This role enables and ensures compliance against health authority regulations and Novo Nordisk requirements… more
- Tris Pharma (Monmouth Junction, NJ)
- …liaison with Product Development (PD)/Quality Assurance (QA)/Quality Control (QC)/ Regulatory Affairs, including reviews/approvals of Change Control Reports (CCRs), ... required documentations and change control activities, in liaison with PD/QA/QC/ Regulatory AffairsDesigns experimental plans; Critically analyzes data and information… 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)
- …Capital Process having participated on a large capital project teamExperience in regulatory compliance expectations across all phases of product development to ... ideas, but also have pragmatic approach to development options, technology selection and regulatory postureDemonstrated working knowledge of FDA , ICH, and other … more
- Twist BioScience (South San Francisco, CA)
- …continuous improvement, technical excellence, robust software development practices, and regulatory compliance .Software Development & Implementation: Oversee the ... platforms (eg, AWS, Azure, GCP) and DevOps practices.Direct experience participating in regulatory audits (eg, FDA inspections) specifically related to custom… more
- Repligen (Waltham, MA)
- …Notifications (SCNs)Evaluate and manage Supplier Change Notifications to ensure compliance with internal and regulatory quality standards.Coordinate ... You will a key role in ensuring the quality, compliance , and performance of Repligen's global supplier base. This...with eQMS systems or digital audit tools Familiarity with regulatory standards ( FDA , GMP, etc.). Excellent communication,… more
- Lundbeck (Fort Wayne, IN)
- … regulatory environment, including Lundbeck policies and procedures and FDA regulations regarding the promotion of pharmaceutical and medical products. Ability ... and patients including the full range of treatment options available. Pharmaceutical Environment/ Compliance - Ability to apply knowledge of pharmaceutical and… more
- BioAgilytix (Durham, NC)
- …and rule-based checks to identify data discrepancies in real-time, enhancing regulatory compliance and minimizing errors.Independently design and configure basic ... that boost lab productivity and keep BioAgilytix ahead of regulatory requirements.Key ResponsibilitiesData Governance & Quality Standards:Develop a foundational data… more
