- 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
- 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
- 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
- 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
- Apex Systems (North Palm Beach, FL)
- …cybersecurity-related regulations at thefederal, state, and internationallevels. Track and document regulatory requirements across sectors such aselectricity, ... We are seeking a detail-oriented and proactiveCybersecurity Regulatory Research Analystto support our efforts in navigating...with a strong research mindset, a foundational understanding of regulatory frameworks, and a desire to contribute to a… 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
- Goldbelt, Inc. (Frederick, MD)
- …with relevant laws, regulations and policies. Lead the development and review of regulatory document for submission to FDA or other National Regulatory ... Responsibilities Essential Job Functions: Serve as a liaison between the AJPEO MRAS regulatory office and product leads to ensure DoD-funded regulatory Sponsors… more
- Wintermute (New York, NY)
- … and commercial risks in a practical manner. Ability to handle and manage regulatory document requests or enquiries and commercial disputes on a day-to-day ... liquidity provision, exchange agreements, trading agreements, software agreements, and others) Regulatory research & compliance guidance: work closely with the legal… 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
- University of Iowa Hospitals & Clinics (Iowa City, IA)
- …maintenance of documents. Maintain regulatory files and binders. Responsible for regulatory process and document preparation used in the implementation and ... Description BASIC FUNCTION Support, conduct and manage the regulatory aspect of clinical trials to deliver and evaluate research protocols and clinical trials in the… more
- Immunome, Inc. (Bothell, WA)
- …and regulatory compliance from early development through commercialization. Responsibilities Document Control & Records Management Serve as the process owner for ... document retrieval and system demonstration during audits and regulatory inspections. Perform and lead continuous improvement initiatives to enhance the… more
- Globus Medical (Audubon, PA)
- …other Clinical Affairs personnel, as needed for IDE and PMA reporting Reviews Document Change Orders for Regulatory compliance, including drawings and labeling ... can resume their lives as quickly as possible. Position Summary: The Regulatory Affairs Specialist assists with drafting, submitting and gaining clearance for 510(k)… more
- Dyne Therapeutics (Waltham, MA)
- …Knowledge of FDA/international regulations, ICH guidelines, and applicable US/international regulatory processes related to document preparation and production ... responsible for the timely preparation of high quality, compliant clinical and regulatory documents. This position is responsible for the medical writing activities… more
- Revival Research Institute, LLC (Evans, GA)
- …sponsors, research team and the Institutional Review Board. Assist with basic regulatory document preparation, with oversight eg study amendments, adverse event ... reporting, protocol deviation reporting. Maintain professional and technical knowledge about Clinical trials. Research participant/family communication, protect patient confidentiality. Preferred Qualifications: Education/ Training: Bachelor's degree in… 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
- Howard County, MD (Ellicott City, MD)
- … changes and policy formulations. Serves as project manager for assigned regulatory guidelines and document updates. Independently completes special projects, ... relevant to the position for which you are applying. The submitted electronic document must outline accurate dates to include (month and year) in association with… 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
- 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
- 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
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