- Merck & Co. (North Wales, PA)
- …for the business process and related activities associated with Global Regulatory Affairs and Clinical Safety (GRACS) Business Development Execution. The primary ... GRACS functional areas, to ensure implementation and maintenance of regulatory activities associated with assigned Company Business Development (BD) Agreements.-… more
- Formation Bio (New York, NY)
- …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...marketing Formation Bio's assets. This role includes the lead regulatory responsibility for support of global registration and life… more
- Insmed Incorporated (NJ)
- …the future of science, we're in. Are you?About the Role:The Associate Director, Regulatory Affairs, CMC will be responsible for reviewing the CMC post approval ... changes, providing regulatory impact assessments, and coordinating with regional RA-CMC leaders...assessments, and coordinating with regional RA-CMC leaders to formulate regulatory strategies for post-approval changes. This role will also… more
- Insmed Incorporated (San Diego, CA)
- …and for the future of science, we're in. Are you?About the Role:The Director, Regulatory Affairs will serve as the regulatory leader on cross-functional teams, ... identifying risks, interpreting regulations and providing guidance to ensure global regulatory compliance and the development of assigned programs in alignment with… more
- Insmed Incorporated (NJ)
- …we're in. Are you?About the Role:This position is a key role that will provide regulatory CMC (RA CMC) leadership and strategy to achieve regulatory approvals in ... candidate will provide knowledge, understanding, interpretation, and utilization of regulatory guidance and regulations from various health authorities, as well… more
- CHRISTUS Health (San Antonio, TX)
- …as promulgated by state and federal agencies, the hospital, and other regulatory entities. Performs all duties in a manner that protects the confidentiality ... of patients and does not solicit or disclose any confidential information unless it is necessary in the performance of assigned job duties. Demonstrates adherence to the core values of Santa Rosa Health Care. Performs other duties as assigned. Requirements:… 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 ... design, computing software and data management; a general understanding of worldwide regulatory requirements; and with good clinical trial experience in Phase II/… more
- LE Cox Medical Centers (Monett, MO)
- …and issues with co-workers and management team. ▪ Familiar and compliant with regulatory agencies and CoxHealth Home Support policy and procedure as it relates to ... Concentrator checks) and understands transfill process. ▪ Familiar and compliant with regulatory agencies and CoxHealth Home Support policy and procedure as it… more
- Merck & Co. (Rahway, NJ)
- …alignment with the company's business goals, and quality and regulatory compliance.-Essential Duties and Responsibilities: Strategic Leadership and Project ... with receiving sites, drug product partners, and Technical Product Leaders, regulatory and quality.Provide Voice of Manufacturing input to early development teams… more
- Merck & Co. (Rahway, NJ)
- …alignment with the company's business goals, and quality and regulatory compliance.-Essential Duties and Responsibilities:Utilize extensive experience in design ... both development and lifecycle management, ensuring compliance with relevant regulatory standards.Ensure robust technical plans, risk communication, drive technical… more
- ValSource, Inc. (Rahway, NJ)
- …client sites, ensuring that pharmaceutical manufacturing processes and systems meet regulatory and quality standards. This role involves extensive travel to various ... activities, and ensuring compliance with FDA, GMP, and other regulatory requirements. ResponsibilitiesOn-Site Project Management: Interface with clients, lead teams… more
- Merck & Co. (Rahway, NJ)
- …alignment with the company's business goals, and quality and regulatory compliance.Essential Duties and Responsibilities:Program Leadership and Technical Project ... with receiving sites, drug product partners,and Technical Product Leaders, regulatory and quality.Provide Voice of Manufacturing input to early development… more
- CHRISTUS Health (San Antonio, TX)
- …core values of the corporation. Directs patient care in compliance with regulatory standards such as Joint Commission and state licensure requirements. Participates ... in the development, communication, and implementation of nursing and organizational policy and procedure. Participates on intra and interdepartmental committees and task forces which are focused on improving patient care. Collaborates with other Department… more
- CHRISTUS Health (Alexandria, LA)
- …in translating policy changes into operational programs and services Healthcare Regulatory Environment Implements programs as needed to comply with diverse ... healthcare laws or regulations Monitors regulatory compliance of all healthcare practices to ensure no violations Evaluates key aspects of pending healthcare… more
- CHRISTUS Health (Beaumont, TX)
- …maintenance of policies and procedures that meet the standards of regulatory agencies and implement service quality improvements. The Laboratory Supervisor ensures ... standards as promulgated by state and federal agencies, the hospital, and other regulatory entities such as CLIA, TJC, CAP, AABB, etc. Plans, organizes and… more
- Merck & Co. (Rahway, NJ)
- …and report clinical laboratory and field studies that will support the regulatory approval of new companion animal and livestock products. The position requires ... and Electronic Data Capture (EDC) clinical studies that meet scientific and regulatory requirements by the setting of objectives, budget, resources, timelines, and… more
- Merck & Co. (Rahway, NJ)
- …device engineering, particularly in the design, manufacturing, and regulatory aspects of Autoinjectors and combination products.Primary Responsibilities:Technical ... and manufacturing of Autoinjectors, ensuring compliance with industry standards and regulatory requirements (eg, ISO 13485, FDA regulations). Actively seek out,… more
- Legend Biotech USA, Inc. (Philadelphia, PA)
- …from early research through IND-enabling studies and into clinical development, ensuring regulatory compliance and scientific rigor in support of our pipeline of ... AAV, lentiviral, gene editing, cell-based therapeutics), a strong understanding of regulatory requirements, and the ability to work cross-functionally in a… more
- Cipla (Hauppauge, NY)
- …and performance of IT systems, contributing directly to product quality and regulatory adherence. You will primarily be responsible for validating and verifying the ... ensuring that all system actions are secure, traceable, and compliant with regulatory standard. Review of the batch records (manufacturing and packaging) to ensure… more
- Merck & Co. (North Wales, PA)
- …teams manage studies to provide the safety and efficacy data required for regulatory approval of potential new drugs, vaccines and new indications for existing ... of clinical development, including study design, initiation, execution,-monitoring, analysis, regulatory reporting, publication, and presentation at national and international… more
