- Insmed Incorporated (San Diego, CA)
- …plansIndependently lead the central messaging, preparation, and submission of high quality , regulatory complaint regulatory dossiersDirect hands-on ... with Regulatory Operations, and/or third-party service providers, ensure high quality , on-time submission activities related to regulatory file maintenance… more
- Merck & Co. (Rahway, NJ)
- …approvals and systems are in place to maintain the scientific, technical and regulatory quality of all CMC submissions, correspondence, and interactions with ... our company. They will lead a team of CMC professionals, ensuring rigorous CMC regulatory strategy and delivery of high- quality submissions for products that may… more
- Insmed Incorporated (NJ)
- …execution of release, stability, and in-process testing in accordance with cGMP, regulatory requirements, and company quality standards. The successful candidate ... in-process control.Ensure external labs operate in full compliance with cGMP, regulatory expectations, and Insmed quality standards. Support inspection readiness… more
- Insmed Incorporated (NJ)
- …internal teams and external partners. The position is critical in shaping quality strategy, managing risk, and supporting regulatory readiness for complex, ... supporting biologics, drug products, or combination products.Deep knowledge of phase-appropriate quality systems, regulatory requirements (21 CFR Parts 210/211,… more
- Insmed Incorporated (San Diego, CA)
- …Director of Clinical Quality Assurance (CQA) serves as a strategic leader managing quality and regulatory compliance related to GCPs, acts as quality ... and guidelines.What You'll Do: Establish and maintain a risk-based and scientific-based quality system to support GCP.Oversee regulatory agency inspections and… more
- Repligen (Waltham, MA)
- …manage Supplier Change Notifications to ensure compliance with internal and regulatory quality standards.Coordinate cross-functional teams to assess and mitigate ... supporting root cause investigations, and ensuring Repligen's supplier network meets regulatory and quality standards. This role is based in Waltham, MA, and… more
- Merck & Co. (Rahway, NJ)
- …advisor for all teams working on Autoinjectors, fostering collaboration among engineering, quality assurance, regulatory , and manufacturing teams across the CMC ... medical device engineering, particularly in the design, manufacturing, and regulatory aspects of Autoinjectors and combination products.Primary Responsibilities:Technical Strategic… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Management to ensure safety information is processed according to corporate timelines, quality and regulatory requirements Leads the safety follow-up process ... 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
- AUROBINDO (Durham, NC)
- …management team with expertise in manufacturing, R&D, Quality Assurance and Quality control and regulatory affairs. In addition to several formulations under ... and compliance7. Cross-Functional CollaborationWork closely with QA, QC, production, and regulatory teams to resolve quality issues.Provide training on… more
- Aequor (Hicksville, OH)
- …occur. Adheres to all applicable procedures, cGMP's, company policies, and all other quality or regulatory requirements (OSHA, DEA, FDA, EMEA, ANVISA, HS&E, ... to service multiple packaging lines simultaneously. Alerts Supervision, Mechanics and Quality personnel of safety, quality and equipment performance problems… more
- Insmed Incorporated (NJ)
- …development program and life cycle management, and ensure they meet current regulatory standards, are of high quality , consistent, and complete.Establish product ... the future of science, we're in. Are you?About the Role:The Associate Director, Regulatory Affairs, CMC will be responsible for reviewing the CMC post approval… more
- BioAgilytix (Durham, NC)
- …tools that boost lab productivity and keep BioAgilytix ahead of regulatory requirements.Key ResponsibilitiesData Governance & Quality Standards:Develop a ... at diagnosing data challenges and designing innovative solutions to improve data quality , integration, and regulatory adherence.Capable of growing with the role… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Management related topics and establishes the oversight model for timely and quality delivery and regulatory compliance of outsourced activities.- Ensures ... to database release, data review and cleaning, database lock), to ensure data quality /integrity and regulatory compliance- Ensures that Data Management Plans are… more
- Merck & Co. (Rahway, NJ)
- …packaging & device development and technology teams, supply chain, operations, quality , analytical, regulatory , and project leaders. The successful candidate ... maintain strong relationships with internal stakeholders, including packaging commercialization, quality , analytical, regulatory , manufacturing, Device Development and… more
- Merck & Co. (Rahway, NJ)
- …manufacturing sites, device development and technology teams, supply chain, operations, quality , analytical, regulatory , and project leaders. The successful ... maintain strong relationships with internal stakeholders, including packaging commercialization, quality , analytical, regulatory , manufacturing, Device Development and… more
- Genscript USA Inc. (Piscataway, NJ)
- …with cross-functional teams is essential to ensure supply continuity, compliance with quality and regulatory standards, and readiness for audit requirements. The ... and consumables used in production, ensuring alignment with cost objectives, quality standards, and regulatory requirements. Develop alternative vendors for… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …investigations and root cause analyses on any supply disruptions or material quality related issues.Support Quality , Regulatory and Financial audits.Provide ... team on implementing supplier performance metrics [e.g. Assurance of Supply, Quality , Service, Cost & Innovation] and develop dashboards/reports.Builds and maintains… more
- Merck & Co. (Rahway, NJ)
- …the Final Study ReportMaintain contact with all stakeholders (project leader, regulatory affairs, quality assurance etc.) and keeps them informed ... and report clinical laboratory and field studies that will support the regulatory approval of new companion animal and livestock products. The position requires… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …investigations and root cause analyses on any supply disruptions or material quality related issues.Support Quality , Regulatory and Financial audits.Provide ... timely responses to business units' representative(s) and suppliers' inquiries.Assist with the development and implementation of standard operating procedures, work instructions and training materials.Support end to end supply chain activities and work… more
- AUROBINDO (Durham, NC)
- …management team with expertise in manufacturing, R&D, Quality Assurance and Quality control and regulatory affairs. In addition to several formulations under ... Must be a Team player able to effectively communicate with the fellow IPQA, Quality Control, Production and Supply Chain to meet finished product release goals. Be… more
