- Daiichi Sankyo, Inc. (Bernards, NJ)
- …industry, with involvement in regulated clinical trials, clinical safety, pharmacovigilance included regulatory document reviewMust have at least 4 or more years ... around rare diseases and immune disorders. SummaryThe Manager Audits & Compliance, GCP/ Document Audits supports end-to-end audit activities per audit program of GxP… more
- Merck & Co. (Upper Gwynedd, PA)
- …risks.Lead the development, communication, lifecycle management and review of the CMC Regulatory Strategy Document for assigned projects.Provide regulatory ... Biological Sciences, Biologics License Application (BLA), Electronic Common Technical Document (eCTD), Immunochemistry, International Regulatory Compliance, Microbiology,… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …standard complexity in design and geographic scope). Prepares clinical section of regulatory document . Collaborates as team member with AROs/CROs. Drafts ... development plans, protocol profiles, and sections of submission documents under guidance of higher level. Reviews and oversee completion of clinical trial protocols. Provides medical and/or scientific direction to Clinical Operations. Represents Clinical… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionPosition Description:The Vice President, Regulatory Affairs, General Medicine, will contribute to the mission and vision of the Global Regulatory ... strategy with US FDA and global health authorities to advocate advanced regulatory strategies for novel medicines.Contributing to the continuous improvement of the… more
- Twist BioScience (South San Francisco, CA)
- The Regulatory Operations Specialist is responsible for ensuring the efficient and compliant management of regulatory documentation, with a primary focus on ... global product compliance, ensuring that all documentation accurately reflects regulatory requirements and product specifications.What You'll Be Doing Initiate,… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …other research areas centered around rare diseases and immune disordersJob Summary: The Regulatory Process Manager will be a key member of the Global Regulatory ... Process Excellence & Analytics function, responsible for ensuring Daiichi Sankyo's Regulatory processes & procedural documentation are fit for purpose and compliant… more
- Merck & Co. (Rahway, NJ)
- …functional area on cross-functional teams to foster collaboration and innovation. Document Excellence: Author regulatory and technical documentation, ensuring ... molecules.Familiarity with late-stage process development, process characterization, process validation regulatory submissions, and working with external contract organizations.Proficiency in… more
- Aequor (Athens, GA)
- …management systems and migration of records from legacy systems. Electronic Document Management (controlled documents, regulatory submission documents): Create ... site users in workflow configuration. Provide routine user support. Electronic Document Management (controlled documents, regulatory submission documents): Be… more
- Carolina PRG (Fort Mill, SC)
- …registrations Equipment certifications Coordinate with vendors, internal stakeholders, and regulatory agencies Document and monitor vehicle maintenance schedules ... professional with a strong accounting background who enjoys managing regulatory filings, certifications, and important operational tasks. Key Responsibilities… more
- USAA (Phoenix, AZ)
- …initiatives including but not limited to: oversight of procedures/process, accurate regulatory reporting and filing, document governance, risk control ... processes and programs while balancing operational efficiency, competitiveness, and regulatory compliance. Implementation may include overseeing business configuration efforts,… more
- Genmab (NJ)
- …a fit? Then we would love to have you join us!The Global Regulatory Labeling, Policy and Intelligence Associate Director will primarily be responsible for leading ... portfolio of products. The lead may also be responsible for supporting various regulatory policy and/or intelligence deliverables. This role will be within Global … more
- Merck & Co. (South San Francisco, CA)
- …and development. PDMB aims to leverage Generative AI (GenAI) to enhance document authoring processes, thereby improving efficiency and compliance in regulatory ... GenAI approaches to streamline the creation and quality control (QC) of regulatory submission documents. The candidate will be part of an interdisciplinary team… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …language in associated contractual templates. Ensures Good Pharmacovigilance Practice and regulatory compliance in such arrangements. Contribute to the management of ... PV Regulatory Intelligence (PVRI) and dissemination across CSPV stakeholders for impact assessment. Participates in the review and management of monthly, quarterly,… more
- Merck & Co. (North Wales, PA)
- …care systems that can enhance value and use of products.Implements programs to document the burden and cost of diseases, unmet medical need, patient reported ... develop OR plans for in-line and developmental products based on the regulatory , marketing and reimbursement environments on a worldwide basis, including the local… more
- Genmab (NJ)
- …Manager to help us tell the story of our science through compelling clinical and regulatory documents. You'll be at the heart of a team that plays a critical role ... development of high-quality clinical documents to support operational, medical, and regulatory activities across the Genmab portfolio. You will help craft… more
- AUROBINDO (Dayton, OH)
- …with expertise in manufacturing, R&D, Quality Assurance and Quality control and regulatory affairs. In addition to several formulations under manufacture, we have a ... direction.4. Record data and results as specified in documentation procedures. Document work clearly and perform tests accurately.5. Prepare and/or Review Test… more
- Aequor (Thousand Oaks, CA)
- …an appropriate risk-based approach, eg. reduced SDV etc Develop and document standard operating procedures (SOPs) for data management activities Process Improvement: ... technologies and ensure smooth integration into new and/or modified processes Regulatory Compliance and Quality Assurance: Ensure all data management activities… more
- Merck & Co. (Rahway, NJ)
- …. - Interacts with key partner organizations such as clinical development, regulatory , quality and other supply chain areas to address clinical supply related ... expertise- - Knowledge of order management, supply chain operations and document control - #MSJR #eligibleforERP GCSCareer25 #VETJOBS #GCSCareer Current Employees… more
- Merck & Co. (Durham, NC)
- …calibration work for the site.Capable technical writing skills, able to document assessments used to justify changes to instrumentation.The successful candidate must ... field calibration, metrology or equipment reliability.Project Management experienceFamiliarity of regulatory requirements in accordance with GMP manufacturing operationsGood oral… more
- Merck & Co. (Durham, NC)
- …calibration work for the site.Capable technical writing skills, able to document assessments used to justify changes to instrumentation.The successful candidate must ... Management experienceStrong planning, scheduling, and time management skillsFamiliarity of regulatory requirements in accordance with GMP manufacturing operationsGood oral… more
