- Eisai, Inc (Philadelphia, PA)
- …If this is your profile, we want to hear from you. The Associate Director of Global Submission Management (GSM) is responsible for leading, managing, ... and overseeing the planning, preparation, coordination, and delivery of global regulatory submissions in compliance with applicable regulations and standards.… more
- Lundbeck (Deerfield, IL)
- Director US Regulatory Global Strategic Labelling...division management at all levels to support regulatory compliance needs. + Highly proficient in ... to candidates in the greater United States** **SUMMARY:** The Director , US Regulatory Affairs Global Strategic Labelling...high quality deliverables. + Responsible for the implementation and compliance management of the Company Core Data… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- … initiatives, such as inspection readiness, metrics implementation and review, overall regulatory compliance and implementation programs, and others as required. ... as well as with all applicable regulatory requirements.Support GxP regulatory inspections as required.Support the local Compliance and auditing teams… more
- SMBC (Jersey City, NJ)
- …+ Lead and contribute to large-scale, cross-functional projects to enhance regulatory compliance infrastructure. + Develop and deliver training materials ... portfolio of benefits to its employees. **Overview** As a Regulatory Policy Director at SMBC you will...complex transactions under US Basel and BCBS frameworks. **Change Management & Implementation** + Advocate for and support the… more
- GRAIL (Carson City, NV)
- …provide direction to regulatory staff and, when required, participate in senior management meetings as a delegate. The role fosters a work culture aligned with ... products, including labeling, promotional materials, product changes, and documentation required for compliance and regulatory approval. + Monitor and report on… more
- Merck & Co. (Rahway, NJ)
- …Programs, FDA Regulations, IT Coordination, IT Operation, Pharmacovigilance, Policy Implementation, Regulatory Compliance , Regulatory Labeling, Regulatory ... BE ONSITE 3 DAYS PER WEEK)The Submissions Content Source Management Business Operations Lead is expected to understand the...industry experience, at least 6 of those in a regulatory and/or compliance area and experience with… more
- Insmed Incorporated (NJ)
- …requires a blend of technical expertise and business acumen to ensure regulatory compliance , system integrity, and alignment with business objectives across ... the Role:This role serves as the IT System Owner for the Learning Management System and compliance IT systems, which includes supporting GxP-regulated… more
- Insmed Incorporated (NJ)
- …with regulatory requirements while maintaining operational excellence. The Executive Director , Cybersecurity & Risk Management plays a critical leadership ... Management and Boards of Directors .Strong understanding of risk management , compliance , and audit processes within regulated industries, ideally… more
- Formation Bio (New York, NY)
- …to bring new treatments to patients faster and more efficiently.About the PositionThe Director of Clinical Project Management will provide overall leadership and ... all clinical trials comply with ICH-GCP, FDA regulations, and other applicable regulatory standards. Champion proactive risk management by identifying and… more
- Insmed Incorporated (NJ)
- …responsible for creating and implementing programs that ensure workplace safety, regulatory compliance , and environmental protection for all Insmed locations.Key ... consultants for instruction in subjects relating to health and safety and regulatory compliance (laws, regulations, requirements). Ensuring the proper execution… more
- Merck & Co. (Rahway, NJ)
- …Detail-Oriented, Name Development, Process Improvements, Professional Presentation, Project Management , Regulatory Compliance , Strategic PlanningPreferred ... the brand while ensuring adherence to internal processes and regulatory guidelines.- To prepare for these launches, we are...for these launches, we are looking for an Associate Director (AD) to join our center of excellence.Description:-Under the… more
- Insmed Incorporated (NJ)
- …company and regulatory policies and procedures. In addition, the Senior Director will be responsible, globally, for implementing the safety and risk ... of risks and appropriate risk minimization and pharmacovigilance measures in compliance with regulatory requirements. Develop/provide input to product… more
- Eisai, Inc (Nutley, NJ)
- …performance, and mitigate operational and regulatory risks. The Senior Director oversees vendor qualification, governance frameworks, and compliance with ... with a proven track record in inspection-facing roles and global regulatory compliance .Essential Functions Clinical Outsourcing Designs and executes outsourcing… more
- Eisai, Inc (NJ)
- …strategies that deliver cost efficiencies, enhance vendor performance, and ensure compliance with regulatory and corporate standards. This role manages ... your profile, we want to hear from you. The Director of Clinical Outsourcing is responsible for leading the...and partner with Vendor Risk Assessment teams to ensure compliance with regulatory requirements and alignment with… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …an immunotherapy 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 OverviewThe Sr. Director of Quality will lead Legend CAR-T manufacturing facilities...United States and ensure the sites operate in full compliance with established cGMP requirements. This individual will be… more
- Merck & Co. (Rahway, NJ)
- …drug substance and drug product container closure systems including mold qualification and regulatory compliance .- To act as master data stewards and support ... Job DescriptionReporting into the Executive Director Packaging Technical Operations the Director ...enterprise wide component specification management as well as maintaining documentation systems for the… more
- BeOne Medicines (San Mateo, CA)
- …changes to the environment. + Lead efforts including but not limited to: IT Policy Management , IT Compliance Management , Training & Awareness Management , ... Director will drive and enforce third party risk management through streamlined third-party risk assessments and third party...Compliance , External Audit, etc). + Strong experience leading regulatory compliance effort for SOX, US DoJ… more
- Micron Technology, Inc. (Boise, ID)
- …compliance , hazardous material handling, and emergency response protocols. + Regulatory Compliance : Guarantee conformance to all applicable environmental laws ... and transformative leader to join our team as the Director - Global Environmental & Chemical Compliance ....all aspects of environmental policies and programs that promote regulatory compliance . + Collaborator Engagement: Work together… more
- Insmed Incorporated (NJ)
- …review and approval process. You will ensure efficient coordination of MRC activities, compliance with company policies and regulatory standards, and the quality ... the future of science, we're in. Are you?About the Role:The Associate Director , Medical Review Committee (MRC) Operations is responsible for managing the operational… more
- Merck & Co. (Rahway, NJ)
- …(PAT), Professional Networking, Quality Control Management , Regulatory Affairs Compliance , Regulatory Compliance , Regulatory Submissions {+ 5 ... affairs, to ensure comprehensive biophysical characterization of products.Ensure compliance with regulatory guidelines and industry standards related… more
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