- Eisai, Inc (Nutley, NJ)
- …industry preferred.Skills:Eisai Salary Transparency Language:The base salary range for the Executive Director , Global Regulatory Affairs - Neurology ... want to hear from you. Job Summary The Executive Director , Regulatory Affairs will provide...Affairs will provide leadership and direction for the global regulatory aspects of Eisai's products under… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …partner side) CDx RA Policy and Intelligence : Keep abreast of the changing global regulatory environment for devices and share/educate CDx department on these ... procedures.Understanding of strategic and tactical role and deliverables of Global Regulatory Strategy in the Drug and Device Development and Commercialization… more
- Merck & Co. (Rahway, NJ)
- …Capability, People Leadership, Policy Implementation, Project Management, Project Tasks, Regulatory Affairs Compliance {+ 4 more}-Preferred Skills:Job Posting ... Job Description Director , Combination Product Regulatory CMC -...processes may also be required. - Provide evaluations of regulatory state of affairs of any devices… more
- Merck & Co. (Rahway, NJ)
- …position will be part of the Device Quality & Regulatory Team within Global Regulatory Affairs and Clinical Safety (GRACS). The primary responsibility ... medical device combination quality system aspects are integratedStay abreast of evolving global regulatory landscapes for medical device and medical device… more
- Merck & Co. (Rahway, NJ)
- …Collaborative Development, Continuous Monitoring, Detail-Oriented, Drug Regulatory Affairs , Employee Training Programs, FDA Regulations, Global ... Leadership, Life Science, Management Process, Mentorship, Microsoft Office, Pharmaceutical Regulatory Affairs , Pharmacovigilance, Process Improvements, Project Management,… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionThe Director , Global Scientific and Value Content-Healthcare Professional (Dir GSVC-HCP) for oncology is a headquarters-based leadership role ... The role has several key responsibilities with in the Global Medical and Scientific Affairs (GMSA) team....to the brands within the team. Anticipating Business and Regulatory Needs: Anticipating internal and external business and information… more
- Merck & Co. (Rahway, NJ)
- …ethics committees, and internal auditors in conjunction with CCQM, compliance, Regulatory , Pharmacovigilance (PV) and Medical Affairs .Responsible and supports ... Job DescriptionThe Executive Director (ED) is the Clinical Operations lead in...and project delivery.A complete understanding of ICH GCP and Global /Regional/Local regulatory requirements is required.Strong Communication skills… more
- Merck & Co. (Rahway, NJ)
- …and leadership of cross functional teams compromised of Global Supply Chain, Global Regulatory Affairs , Labeling, Material Master Data, Finance, Quality, ... of switch plans with all relevant stakeholders (Donor & Receiving Sites, Global Regulatory Affairs (Labelling), Quality and the Material Master Data… more
- Eisai, Inc (Nutley, NJ)
- …difference. If this is your profile, we want to hear from you. The Associate Director (AD), Global Medical Affairs Training and Education is responsible for ... & International). Eisai Salary Transparency Language:The base salary range for the Associate Director , Global Medical Affairs Training and Education is from… more
- Merck & Co. (Rahway, NJ)
- …(release) activities. Background in quality control, quality assurance, auditing or regulatory affairs .- Effectiveness and creativity in approaching and solving ... Quality Control Management, Quality Management, Quality Management Standards, Quality Standards, Regulatory Affairs Compliance, Regulatory Compliance, Risk… more
- Merck & Co. (Rahway, NJ)
- …(release) activities.Background in quality control, quality assurance, auditing or regulatory affairs .-Effectiveness and creativity in approaching and solving ... Quality Management, Quality Risk Management, Quality Standards, Quality Systems Compliance, Regulatory Affairs Compliance, Regulatory Compliance Audits,… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …including working with contract manufacturing organizations CMO. This position serves as the Regulatory Affairs (RA) CMC project representative to the CMC sub ... medicines to help people. Under the Group's 2025 Vision to become a " Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi Sankyo is primarily… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …rare 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 with the Global Oncology Medical Affairs (GOMA), Oncology Business Unit (OBU) and Specialty… more
- Eisai, Inc (Nutley, NJ)
- …strategic imperatives for assigned therapeutic area(s). Collaborate with other stakeholders across Global & US Medical Affairs functions and regions, in addition ... If this is your profile, we want to hear from you. Associate Director , Medical Education - Oncology, is responsible for the strategic planning and execution… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …will collaborate globally with Formulation and Analytical Scientists, Clinical Operations, Regulatory Affairs CMC, and Clinical Development to collate the ... for cardiovascular diseases, under the Group's 2025 Vision to become a " Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi Sankyo is primarily… more
- Sanofi Group (Morristown, NJ)
- **Job Title:** Associate Director , Global Regulatory Affairs - Global Labeling Strategy **Location** : Morristown, NJ or Cambridge, MA (Hybrid) ... Your skills could be critical in helping our teams accelerate progress. The Associate Director , Global Regulatory Affairs - Global Labeling Strategy… more
- Sanofi Group (Morristown, NJ)
- **Job Title:** Director , Global Regulatory Affairs - Global Labeling Strategy **Location** : Morristown, NJ or Cambridge, MA (Hybrid) **About the ... families. Your skills could be critical in helping our teams accelerate progress. The Director , Global Regulatory Affairs - Global Labeling Strategy… more
- J&J Family of Companies (Raritan, NJ)
- …more at https://www.jnj.com/innovative-medicine **We are searching for the best talent for a Director , Global Regulatory Affairs (Business Integration ... and profoundly impact health for humanity. Learn more at https://www.jnj.com **Job Function:** Regulatory Affairs Group **Job Sub** **Function:** Regulatory … more
- Gilead Sciences, Inc. (Parsippany, NJ)
- …to fulfil their aspirations. Join Gilead and help create possible, together. **Job Description** Regulatory Affairs Global Labeling is a core function within ... Gilead's Global Regulatory Affairs organization and acts as a critical strategic partner across cross-functional teams. Regulatory Affairs Global … more
- Bausch Health (Bridgewater, NJ)
- …writing CCDS and USPI documents for new products. + Solid understanding of pharmaceutical regulatory affairs , global labeling regulatory requirements and ... skills and values drive our collective progress and impact. The Global Labeling Director provides regulatory expertise and guidance for labeling strategy,… more
