- 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
- Phoenix Closures, Inc (Aurora, IL)
- …Review reports, identify issues, and perform actions to correct/resolve issues in the regulatory document libraries in the ERP system. Assist in entering new ... requirements for incoming raw materials and outgoing finished products. Prepare document submissions and responses to customer regulatory requests, such as:… 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
- Sutro Biopharma (South San Francisco, CA)
- …of scientific writing and will work cross-functionally, advising the team on regulatory expectations for document content while maintaining compliance with ... global (FDA, EMA, ICH) regulatory expectations for document content. Experience in oncology drug development is preferred. Responsibilities: Independently… 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
- Syntricate Technologies (New York, NY)
- …of our regulatory reporting, including clear communication and escalation as required. Document & own regulatory gaps and finding and manage business process ... Business Analyst/ Regulatory Reporting/ CFTC New York City, NY (Hybrid...CFTC Reg Reporting specialist/SME consultant who focuses only on Regulatory . We need A senior technical Business Analyst… 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
- Cedent (Boston, MA)
- …(IND/IDE, amendments) Ensure completeness and compliance of essential documents Manage regulatory document workflows and tracking systems Support eTMF management ... CRO Regulatory Specialist Job Description The Regulatory Specialist ensures clinical trials operate within a compliant framework while supporting sponsors and… more
- Merck & Co. (Boston, MA)
- …current with emerging pharmaceutical information tools and databasesSupporting document delivery requests and end-user requestsObtaining journal articles and ... clearly and concisely to diverse audiences, including researchers, clinicians, regulatory affairs professionals, and other stakeholdersCustomer Focus - Driven to… 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
