- Insmed Incorporated (NJ)
- …QC of regulatory documents prior to submission.Ensure adherence to global regulatory authority technical requirements ( FDA , EMA, Health Canada, MHRA, etc.) ... submission trackers, and regulatory archives.Partner with cross-functional teams ( Regulatory Affairs, CMC, Clinical, Quality ) to facilitate document… more
- Insmed Incorporated (NJ)
- …for documentation review prepared by other technical functions and will act as the primary regulatory contact for the US FDA . The GRL will be accountable for ... submissionsProvide oversight for preparation and delivery of materials for regulatory agency meetingsPrepare and deliver high- quality presentations for both… more
- Merck & Co. (Rahway, NJ)
- …process inefficiencies using operational excellence tools and ensuring alignment with global regulatory requirements (eg, FDA 21 CFR Part 820, ISO 13485, ... cross-function teams to improve processes related to device-drug integration. Partner with Quality and Regulatory teams to ensure compliance with applicable… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …compliance, clinical quality , or cell therapy.Knowledge of cGMP regulations and FDA /EU guidance related to manufacturing of cell based products as well as ... multiple myeloma.Legend Biotech is seeking Head of Compliance as part of the Global Quality team based in Raritan, NJ. Role OverviewThe Head of Compliance will be… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …compliance, clinical quality , or cell therapy.Knowledge of cGMP regulations and FDA /EU guidance related to manufacturing of cell based products as well as ... in the treatment of multiple myeloma.Legend Biotech is seeking a Senior Director of Quality Operations as part of the Quality team based in Raritan, NJ.Role… more
- ValSource, Inc. (Rahway, NJ)
- …at client sites, ensuring that pharmaceutical manufacturing processes and systems meet regulatory and quality standards. This role involves extensive travel to ... validation and equipment qualification activities, and ensuring compliance with FDA , GMP, and other regulatory requirements. ResponsibilitiesOn-Site Project… more
- Syner-G BioPharma Group (Boston, MA)
- …We provide strategic guidance and hands-on expertise to streamline operations, enhance quality systems, and ensure regulatory compliance, empowering our clients ... parameters, and the commissioning/validation of manufacturing processes for compliance with quality and regulatory requirements.Provide technical support for the… 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
- Cipla (Fall River, MA)
- …and maintenance of the QMS in line with GMP (Good Manufacturing Practice) and regulatory requirements (eg, FDA , ). Maintain and ensure the proper documentation ... requirements. Ensure that the company remains compliant with all regulatory requirements (eg, FDA , ICH, EMA). Support...monitoring etc. Preparation and review of the Annual Product Quality Review. Fulfil the requirement of regulatory … more
- 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
