- Daiichi Sankyo, Inc. (Bernards, NJ)
- …and provide US regulatory support; meet aggressive deadlines to ensure that FDA receives timely and quality submissions, shortening the review process and ... partnering with FDA . This role will create and implement effective regulatory strategies to deliver on efficient and robust development plans. The individual… more
- Repligen (Waltham, MA)
- …Director, Global Regulatory Affairs will report directly to the VP, Global Quality .This role will be accountable for the Regulatory oversight of all Repligen ... as neededMaintains regulatory compliance through continuous monitoring of International regulatory standards (eg WHO, EMA, FDA , ISO)Develops & maintains… more
- Formation Bio (New York, NY)
- …the pharmaceutical quality management system (QMS) to ensure compliance with regulatory requirements (eg, FDA , EMA), industry standards (eg, cGMP), and ... In-depth knowledge of regulatory requirements and guidelines governing pharmaceutical quality assurance, including FDA regulations and ICH guidelines. Proven… more
- Merck & Co. (Durham, NC)
- …independently and within a team environmentPreferred:Experience with responding to regulatory questions with multiple agencies ( FDA , EMA, JNDA,).Experience ... ingredient, finished product, and laboratory testing for the BCG vaccine.The Specialist, Quality Control participates in a team of analysts in the development,… more
- Tris Pharma (Monmouth Junction, NJ)
- …Documentation Practices (cGDPs) within pharmaceutical industryExperience implementing and managing quality systems and processesFamiliar with US FDA guidance ... Junction, New Jersey, Tris has an immediate opening for a Manager, Quality Management Systems (QMS). Summary:The Manager, Quality Management Systems (QMS)… more
- Exela Pharma Sciences, LLC (Lenoir, NC)
- …Deviations, and other quality documents for cGMP compliance and consistency with FDA regulations. Aiding members of the Quality Department in developing and ... Quality Execution CoordinatorPosition Summary:The Quality Execution...Fostering efficiency, maintaining compliance with cGMP and other relevant regulatory requirements, and fostering continuous improvement are the key… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …within the organization. From health-care-provider interactions and developing and implementing regulatory strategies with the FDA to providing medical education ... find better and more innovative ways to improve their quality of life. We're changing lives for a living....the Vice President, CMR Strategic Operations. External relationships include regulatory authorities: FDA and MDR and relevant… more
- Formation Bio (New York, NY)
- …will play a key role in shaping innovative trial designs, supporting regulatory strategies, and ensuring high- quality statistical contributions across clinical ... and Business Development teams to support drug diligence, development and regulatory interactions, FDA briefing books, and submission-related activities.… more
- Novo Nordisk Inc. (Boulder, CO)
- …us. Our R&D hub merges biotech speed and agility with large pharmaceutical company quality , resources, and stability, uniting the best of both worlds to develop new ... medicines for patients. The Position Novo Nordisk is seeking a Quality Control Manager to support the successful start-up of the Quality Control laboratory… 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 investigations under the direction of a supervisor.8. Comply with all regulatory /in-house requirements (may include but not limited to safety, house keeping,… more
- Novo Nordisk Inc. (West Lebanon, IN)
- …facility regulated by the FDA , EMEA or a leading international regulatory agency preferred As applicable, experience with Quality Assurance oversight and ... to a better tomorrow for our patients. Ethics and quality are held in the highest regard, and a...and assesses Corrective and Preventive Action Reports Participates in Regulatory Inspections Other duties as assigned Performs all job… 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 ... the accuracy of analytical measurements and compliance with cGMP, US FDA , and other regulatory and corporate requirements.Conducting troubleshooting and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …diseases and immune disorders. JOB SUMMARYThe Senior Director, Head Medical affairs Quality Assurance in Global RD/PV QA is accountable to drive the implementation ... of a quality strategy and quality plan closely aligned...preparedness for the respective MA inspections in alignment with regulatory and company strategy. Act as management representative for… more
- Formation Bio (New York, NY)
- …and/or pharmacovigilance documents are developed in a format compliant with the governing regulatory agency (EMA, FDA , and ICH guidelines) and with electronic ... managing other writers (internal or contract) preferred. Understanding of FDA /international regulations, ICH guidelines, and applicable US/international regulatory… more
- Exela Pharma Sciences, LLC (Lenoir, NC)
- …of deviances and variances that occur during production or validationWork with Quality , Manufacturing, Regulatory , and subject matter experts to prepare for ... support of commercialization. Serve as a technical resource to improve product quality , reliability, and process capability. Support manufacturing to satisfy the … more
- Formation Bio (New York, NY)
- …knowledge of regulatory requirements and guidelines governing pharmaceutical quality assurance, including FDA regulations and ICH guidelines. Demonstrated ... CMC, Regulatory Affairs, Clinical Operations) to ensure alignment on quality objectives, initiatives, and priorities. Stay abreast of changes in regulations,… more
- Merck & Co. (Rahway, NJ)
- …controls areaKnowledge of US and global medical device and healthcare regulations, including FDA combination products cGMP, Quality System Regulation, FDA ... from early design concept definition through commercialization to support regulatory filing, product launch, and post-market surveillance.This position will interact… more
- Formation Bio (New York, NY)
- …that all clinical trials are conducted in accordance with ICH-GCP guidelines, FDA regulations, and other applicable regulatory requirements. Ensure that clinical ... executed efficiently, on time, and in compliance with all regulatory requirements. The Director will manage a team of...trials are conducted to the highest quality standards, with a focus on patient safety, data… more
- Exela Pharma Sciences, LLC (Lenoir, NC)
- …accuracy of laboratory documentation.Help with the implementation and interpretation of applicable quality and regulatory requirements (eg, FDA , GLP, QSR, ... new product support.Operate and troubleshoot procedures for lab equipment, and quality and regulatory requirements important to pharmaceutical and combination… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …- 7 or more years training and compliance background and strong knowledge of FDA and EU regulatory requirements, industry audit processes, and Data Management ... clinical safety and pharmacovigilance, CROs and other vendors to ensure high quality of deliverables to support drug development processes and global submissions.… more
