- Novo Nordisk Inc. (Plainsboro, NJ)
- …to make a difference? The Position We are seeking a dynamic and experienced Regulatory Affairs Labeling Associate Manager to oversee and lead critical tasks ... About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one of the most diverse and collaborative groups within the… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …other research areas centered around rare diseases and immune disorders. Summary The Manager , Regulatory Affairs Labeling position will provide Regulatory ... for global labeling projects. Under the direction of the labeling leadership, the manager will develop, review and revise labeling for FDA submission, create and… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionThe regulatory operations senior specialist supports cross-functional or departmental projects related to regulatory operations. This role will ... be responsible for supporting all aspects of the submission process for regulatory documents to health authorities. This includes assisting with the planning,… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one of the most diverse and collaborative groups within the ... organization. From health-care-provider interactions and developing and implementing regulatory strategies with the FDA to providing medical education and collecting… more
- Lovelace Biomedical Research Institute (Albuquerque, NM)
- …GSA, Federal, HHS and DCA audits and prepare and file all necessary governmental regulatory reports and plans.The Manager will also oversee the daily operations ... Director of Research Administration and under limited direction, the Contracts Manager - Federal Contracts and Compliance, will oversee end-to-end contract… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …around rare diseases and immune disorders. Summary The purpose of the Project Manager (RACMC) function is to lead and/or support complex filing activities, ensuring ... compliance with technical and regulatory standards. This role involves efficient resource management, and clear communication with stakeholders and the project team.… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …IND, IB, NDA, Amendments, Supplements, Briefing Books) for review by higher-level manager . This position demonstrates understanding of key regulatory guidances ... around rare diseases and immune disorders. Summary: This position serves as the Regulatory Affairs (RA) CMC project representative to the CMC sub team and the… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …highest standards of scientific rigor and ethics. The Senior Global Medical Manager will drive and collaborate with cross-functional teams to develop, implement, and ... professionals though robust medical education initiatives. The Senior Global Medical Manager will leverage data-driven insights and foster strong relationships with… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …pull you in? Are you ready to experiment with us? The Position The HCP Manager will be a critical driver in driving engagement within field teams by overseeing the ... and finance teams to ensure alignment with business objectives and regulatory requirements. Essential Functions Field Promotion Content: Develop creation of… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- Legend Biotech is seeking a QA Laboratory Compliance Manager as part of the Quality team based in Raritan, NJ. Role OverviewThe QA Laboratory Compliance Manager ... many stakeholdersLead continuous improvement associated with laboratory investigation managementSupport regulatory inspections and audits by ensuring inspection readiness at… more
- Genmab (Plainsboro, NJ)
- …is essential to fulfilling our purpose.Genmab is seeking a Clinical Drug Supply Manager to join our Global Clinical Drug Supply (GCDS) Operations Team in Princeton ... to our hybrid work arrangement.Responsibilities/tasks:Act as Clinical Drug Supply Manager , of the following tasks:Global Clinical Drug Supply Project/Trial… more
- Novo Nordisk Inc. (West Lebanon, IN)
- …is eligible for selected candidate. The level and title of this Project Manager will be commiserate with experience. Relationships Reports to: Manager of ... and performance metrics for all projects under guidance of tenured project manager Lead cross functional teams focused on improving manufacturing or business… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …drive and shape the quality landscape across regions. This may include assessing regulatory intelligence and industry best practices and sharing with the BPQLs and ... PV/MA Quality).Participate and support lessons learned activities from audits, regulatory authority inspections, and internal process deviations delivered to program… more
- Tris Pharma (Monmouth Junction, NJ)
- …in Monmouth Junction, New Jersey, Tris has an immediate opening for a Manager , Quality Management Systems (QMS). Summary:The Manager , Quality Management Systems ... not limited to: investigative processes, CAPAs and CPIs, etc.Participates in regulatory agency inspections and customer audits, as needed; Performs and/or… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …in? Are you ready to experiment with us? The Position The Consumer CX Manager will be a critical driver in ensuring the successful execution of brand/therapy area ... services Proven knowledge of the pharmaceutical industry, including medical, regulatory , clinical processes and market dynamics, especially within specified therapy… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …in? Are you ready to experiment with us? The Position The HCP CX Manager -CV/Renal will be a critical driver in ensuring the successful execution of brand/therapy ... required Proven knowledge of the pharmaceutical industry, including medical, regulatory , clinical processes and market dynamics, especially within specified therapy… more
- Genmab (Plainsboro, NJ)
- …and authentic is essential to fulfilling our purpose.Overview The Global Clinical Trial Manager , Team Manager (GCTM-TM) is responsible for line management of ... support across trials as needed and may assume Global Clinical Trial Manager (GCTM) responsibilities to address fluctuating demands throughout the trial lifecycle.… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …well as FDA regulation requirements, industry best practices and will withstand regulatory inspections by regulatory authorities and regular audits.Drug Product ... ADC Team Members, Pharmaceutical Technology, QA-GMP and QA RD functional areas, Regulatory Affairs - CMC, Pharmacovigilance, Medical Affairs and Supply Chain) to… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …the timely release and delivery of pharmaceutical products as per applicable regulatory standards and company expectations for products. The incumbent is responsible ... Programs to assure product quality, integrity and compliance with regulatory guidelines and internal/global standards and procedures. Responsible for managing… more
- Merck & Co. (Rahway, NJ)
- …arms within the business.-- - - The Program Clinical Supplies Project Manager (Program CSPM) serves as the primary program-level GCS point of contact ... as a lead GCS Planning program representative ) such as clinical development, regulatory , quality and other supply chain areas to negotiate timelines ,- strategies… more
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