- Merck & Co. (North Wales, PA)
- …in a global pharmaceutical/biotech setting.Strong knowledge of international healthcare systems, access and reimbursement landscapes, and compliance ... with global and ex-U.S. commercial, medical, access, policy, and compliance stakeholders to ensure that Therapy Patient Programs (TPPs) outside of the… more
- Eisai, Inc (Philadelphia, PA)
- …managing, strategizing, and overseeing the planning, preparation, coordination, and delivery of global regulatory submissions in compliance with applicable ... budgeting, vendor management, and technical oversight to support the objectives of Global Regulatory Operations. The Associate Director will collaborate with the… more
- Merck & Co. (Rahway, NJ)
- …to define and implement user requirements, workflows, and metadata standards. Ensure compliance with global regulatory standards and internal SOPs ... - Functional Area: Regulatory Innovation and Information Management (RIIM) within Global Regulatory Affairs & Clinical Safety (GRACS) - The Associate… more
- Eisai, Inc (Bethesda, OH)
- …is responsible for the leadership and oversight of the Labeling function within Global Regulatory Services and Operations (GRSO). This position will manage ... regulations governing labeling of pharmaceutical products globally, and serves as the global regulatory labeling representative on relevant project teams to… more
- Merck & Co. (Rahway, NJ)
- …Name Development, Process Improvements, Professional Presentation, Project Management, Regulatory Compliance , Strategic PlanningPreferred Skills: Current ... optimize and obtain trademark approval in time for health authority submissions.Leads regulatory submission and rejection strategies for global , regional, and… more
- Formation Bio (New York, NY)
- …to developing and marketing Formation Bio's assets. This role includes the lead regulatory responsibility for support of global registration and life cycle ... to patients faster and more efficiently.About the PositionThe Senior Director, Regulatory Affairs lead is responsible for developing and directing the regional… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …At Novo Nordisk, you will have the opportunity to build a career in a global business environment. We encourage our employees to make the most of their talent, and ... of 340B as well as Inflation Reduction Act ("IRA") processes and compliance activities for the Medicare Drug Negotiation Program. Ensures accurate and timely… more
- Merck & Co. (Rahway, NJ)
- …device-drug integration. Partner with Quality and Regulatory teams to ensure compliance with applicable global regulations. Leverage data analytics and key ... identifying process inefficiencies using operational excellence tools and ensuring alignment with global regulatory requirements (eg, FDA 21 CFR Part 820, ISO… more
- Merck & Co. (Omaha, NE)
- …Documentations, External Liaison, Foreign Trade, Foreign Trade Policy, International Regulatory Compliance , Inventory Management, Key Performance Indicators ... Job DescriptionThis position within our company's Global Clinical Supply Compliance Operations responsible for ensuring imports/exports are declared and shipped… more
- Eisai, Inc (Nutley, NJ)
- …essential, along with a proven track record in inspection-facing roles and global regulatory compliance .Essential Functions Clinical Outsourcing Designs and ... across the organization. Collaboration is central, working closely with Finance, Legal, Regulatory & Compliance , IT Security, and Clinical teams to align… more
- Cipla (Fall River, MA)
- …on time, ensuring accuracy and completeness. Adhering to all cGMPs, compliance / regulatory mandates and quality requirements. Complying with company policies ... posting for local applicants only - is not for those applying for a global assignment and/or for employees working outside of Cipla's US Subsidiaries or Affiliates.… more
- Merck & Co. (North Wales, PA)
- …Data Analysis, Data Management, Data Science, Numerical Analysis, Project Management, Regulatory Compliance , Regulatory Requirements, Scientific Leadership, ... art scientific methodologies and tools to enable the discovery, development, regulatory approval, manufacturing, and marketing of medical drugs and vaccines for… more
- Cipla (Fall River, MA)
- …on time, ensuring accuracy and completeness. Adhering to all cGMPs, compliance / regulatory mandates and quality requirements. Complying with company policies ... efficient execution of their job duties, while ensuring product compliance to established standards.Essential Duties and Responsibilities: Understanding basics of… more
- Cipla (Fall River, MA)
- …on time, ensuring accuracy and completeness. Adhering to all cGMPs, compliance / regulatory mandates and quality requirements. Complying with company policies ... efficient execution of their job duties, while ensuring product compliance to established standards.Essential Duties and Responsibilities: Understanding basics of… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …strategies to guide customer experiences Strong understanding of regulatory , compliance , and ethical considerations in engaging with healthcare providers ... teams, including sales, medical affairs, market access and policy/advocacy (MAPA), Global Commercial, regulatory affairs, other relevant NNI departments.… more
- Merck & Co. (North Wales, PA)
- …art scientific methodologies and tools to enable the discovery, development, regulatory approval, manufacturing, and marketing of medical drugs and vaccines for ... the benefit of patients and global human health.- Responsibilities: This position supports statistical programming activities for late stage drug/vaccine clinical… more
- Cipla (Fall River, MA)
- …independently and as part of a team. Capable of handling and participating in compliance and regulatory audits at the local and federal levels. Experience in ... standard operating procedures (SOPs) Monitor operational metrics such as efficiency, compliance rates, and resource utilization. Identify areas for improvement in… more
- Cipla (Fall River, MA)
- …machines. Capable of conducting trouble-shootings. Capable of handling and participating in compliance and regulatory audits at the local and federallevels. ... absence of the Packaging Supervisor. The Packaging Supervisor ensures compliance with cGMP's, InvaGen Pharmaceutical's policies,standard operating procedures, and… more
- Merck & Co. (Rahway, NJ)
- …art scientific methodologies and tools to enable the discovery, development, regulatory approval, manufacturing, and marketing of medical drugs and vaccines for ... the benefit of patients and global human health.This position supports statistical programming activities for multiple and/or late stage drug/vaccine clinical… more
- Cipla (Central Islip, NY)
- …in-process samples, finished products to ensure they meet quality standards and regulatory requirements. Understanding of regulatory compliance , quality ... only - is not for those applying for a global assignment and/or for employees working outside of Cipla's...ensure compliance within the systems etc. Maintaining regulatory compliance in accordance with cGMP and… more
