- Formation Bio (New York, NY)
- …new treatments to patients faster and more efficiently.About the PositionThe Senior Director , Regulatory Affairs lead is responsible for developing and directing ... the regional regulatory strategy, objectives, policies, and programs pertaining to developing...to all appropriate departments in Formation Bio to assure compliance with applicable regulations. Remains knowledgeable about current regulations… more
- Lundbeck (Deerfield, IL)
- …problems. + Ability to influence division management at all levels to support regulatory compliance needs. + Highly proficient in communicating strategic and ... Director US Regulatory Global Strategic Labelling...change requests. + Provides high-level RA advice and identifies regulatory requirements for labeling development and compliance … more
- SMBC (Jersey City, NJ)
- …+ Lead and contribute to large-scale, cross-functional projects to enhance regulatory compliance infrastructure. + Develop and deliver training materials ... a competitive portfolio of benefits to its employees. **Overview** As a Regulatory Policy Director at SMBC you will be the authoritative source on the… 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
- Post Holdings Inc. (Lakeville, MN)
- …about pet nutrition and regulatory excellence? Join our team as the **Associate Director of Pet Food Regulatory Affairs** , where you'll lead a talented team ... and shape the future of pet food compliance , labeling, and product claims. This is a high-impact...high-impact leadership role that blends strategic oversight with hands-on regulatory expertise. **What You'll Do** + **Lead and inspire**… more
- GRAIL (Carson City, NV)
- …products, including labeling, promotional materials, product changes, and documentation required for compliance and regulatory approval. + Monitor and report on ... For more information, please visit grail.com . The role assists with regulatory strategy and the development of submissions in partnership with key internal… 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 ... as the IT System Owner for the Learning Management System and compliance IT systems, which includes supporting GxP-regulated applications, while also functioning as… more
- Eisai, Inc (Philadelphia, PA)
- …and overseeing the planning, preparation, coordination, and delivery of global regulatory submissions in compliance with applicable regulations and standards. ... vendor management, and technical oversight to support the objectives of Global Regulatory Operations. The Associate Director will collaborate with the Heads… 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)
- …Name Development, Process Improvements, Professional Presentation, Project Management, Regulatory Compliance , Strategic PlanningPreferred Skills: Current ... 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
- 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
- Insmed Incorporated (NJ)
- …company and regulatory policies and procedures. In addition, the Senior Director will be responsible, globally, for implementing the safety and risk management ... of risks and appropriate risk minimization and pharmacovigilance measures in compliance with regulatory requirements. Develop/provide input to product… more
- Merck & Co. (Rahway, NJ)
- …development strategy, study design, initiation, execution, monitoring, analysis, regulatory reporting, and publication.Specifically, the Senior Director ... Job DescriptionThe Senior Director (Sr. Principal Scientist) has primary responsibility for...closely with a cross-functional group of experts in commercialization, regulatory affairs, statistics, and manufacturing to manage clinical development… 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 ...and continuous improvement initiatives to guarantee the robustness and compliance of our company's product portfolio across the internal… 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
- BeOne Medicines (San Mateo, CA)
- …Control, Legal & Compliance , External Audit, etc). + Strong experience leading regulatory compliance effort for SOX, US DoJ Data Rule. + Experience in ... **General Description:** BeOne is seeking an Associate Director of GTS Governance, Risk, & Compliance...and improving policies, procedures and internal controls to ensure compliance with applicable regulatory and legal requirements… more
- Merck & Co. (Rahway, NJ)
- …Technology (PAT), Professional Networking, Quality Control Management, Regulatory Affairs Compliance , Regulatory Compliance , Regulatory Submissions ... affairs, to ensure comprehensive biophysical characterization of products.Ensure compliance with regulatory guidelines and industry standards related… more
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