- Transdev (Readville, MA)
- …Workers' Compensation insurer. Creates employee injury reports. Ensures compliance with the Drug and Alcohol Policy, Safety Policies & Procedures, and other company ... Two (2) years of experience in a supervisory or management position. Experience Preferred: Safety training/teaching experience preferred. Experience investigating… more
- BeOne Medicines (Emeryville, CA)
- …to new software platforms and digital collaboration tools. + Experience with electronic document management systems and regulatory submission platforms is ... the global drug development lifecycle. This role combines deep regulatory expertise with advanced project management and organizational leadership, driving… more
- BeOne Medicines (Emeryville, CA)
- …the global drug development lifecycle. This role blends deep regulatory expertise with advanced project management skills, driving successful NDA/BLA/MAA ... **General Description:** The Associate Director, Global Regulatory Project Management (AD, Global RPM)...fostering open communication across cultures. + Proficiency with project management and document management tools… more
- Parsons Corporation (Centreville, VA)
- …as‑built records, O&M manuals). Understanding of legal/contractual obligations related to document management , records retention, and claims support in the ... Manager** to join our growing team! In this role you will lead document control and records management for a multi‑billion‑dollar infrastructure capital program.… more
- Lilly (Indianapolis, IN)
- … team. The GRL is responsible for the creation and maintenance of the Regulatory Strategy Document (RSD) and ensures local plans, created by the regional ... Global Regulatory Strategy - Initiate and Update Regulatory Strategy Document (RSD)_ + Obtain input...(ie, PhD, PharmD) and 8+ years Industry-related experience in regulatory affairs and/or drug development experience OR… more
- Saint-Gobain (Clearwater, FL)
- **Quality Document Control Technician, Manufacturing Facility, Clearwater, FL** If you want to reshape the world and discover your greatest potential, Saint-Gobain ... our efforts on the world around us. **The Quality Document Control Technician will ensure that the controlled documents...Assurance Support** + Supplier assessments with QE support. + Regulatory requests first point of contact. + Assists Engineers… more
- Otsuka America Pharmaceutical Inc. (Raleigh, NC)
- …Office programs (Word, Excel, PowerPoint, Outlook) and familiarity with electronic document management systems (EDMS). **Competencies** See OPDC Competencies ... strategy, planning and execution of global investigational and marketed prescription drug submissions and manages lifecycle regulatory activities in alignment… more
- Otsuka America Pharmaceutical Inc. (Augusta, ME)
- …tools and systems needed for the function including and not limited to CREDO ( document management ), PRISM ( regulatory information management system), ... investigational filings, marketing applications (NDA/MAA), global submissions, and post-marketing lifecycle management as the CMC Regulatory lead. + … more
- Ascendis Pharma (Palo Alto, CA)
- …The Regulatory Project Manager will be an integral part of Global Regulatory Affairs, providing project management leadership to key global regulatory ... ensure the delivery of business objectives. + Participate in Regulatory filing teams, providing project management expertise...minimum of 8 years of experience: 5 years in drug , biologic and/or combination products in Regulatory … more
- DriveTime (Mesa, AZ)
- …But What's the Job?** This position is responsible for being proficient in Document Control Coordinator tasks and ability to take on additional assignments and ... Complete lien verifications for internal and external departments + Complete document replacement requests + Provide excellent internal and external customer service… more
- University of Pennsylvania (Philadelphia, PA)
- …Microsoft Teams, Zoom, Webex, etc. Knowledge and/or experience working with web-based e- regulatory document management systems such as eFlorence, Veeva ... programs and resources, and much more. Posted Job Title Associate Director, Regulatory Job Profile Title Associate Director, Clinical Research Regulatory Job… more
- Takeda Pharmaceuticals (Boston, MA)
- … authoring, submission publishing/validation/viewing, registration and commitment tracking, and regulatory document archiving. + Experience with regulatory ... eCTD4, SPOR/IDMP, and CTIS/EU CTR. + Oversee master data management for regulatory data and partner/ drive...regulatory processes and technology for submission document… more
- Grifols Shared Services North America, Inc (San Diego, CA)
- …+ Exceptional computer skills in Microsoft Office, Adobe, Excel + Knowledge in document management control systems (eg LSQM), change control systems (eg SAP), ... experience in Regulatory Affairs. Prior experience in the IVD or Drug /Biologics industry is required. **Primary responsibilities for role:** + Prepares and files… more
- TECO Energy (Tampa, FL)
- …Sector Pipeline Regulation Case Management Federal and State Regulations Document Submission Regulatory Research Stakeholder Liaison Data Analysis Intranet ... to federal and state regulatory agencies. This role maintains the Regulatory Affairs case management system website and utilizes FERC-mandated and… more
- Dana-Farber Cancer Institute (Boston, MA)
- …compliance for the disease group. Implementing systems to monitor and ensure regulatory document collection and maintain compliance and audit-ready state. Assist ... as well as assist with FDA submissions and IND management . Reporting to the CTIP Associate Director for the...Support the disease team's IND/IDE applications to the appropriate regulatory agencies including the Food and Drug … more
- Grifols Shared Services North America, Inc (Research Triangle Park, NC)
- … compliance with the ability to propose solutions or escalate to upper management . + Review, monitor and coordinate regulatory meetings to review surveillance ... organizations similar to or including the US Food and Drug Administration (FDA), Clinical Laboratory Improvement Amendments (CLIA), Plasma...document in detail to ensure accuracy based on regulatory requirements, and to ensure the use of the… more
- Bristol Myers Squibb (Princeton, NJ)
- …while ensuring early integration of precision medicine approaches-including coordination of key regulatory and clinical documents to support drug and diagnostic ... in clinical studies-in partnership with the Precision Medicine Lead + Provide regulatory support on product partnership, vendor management and business… more
- Chiesi (Cary, NC)
- …Quality, Commercial). + Supporting internal process improvement initiatives, including document management , compliance tracking, or knowledge-sharing activities. ... with an expected graduation of fall 2026 or later. + Strong interest in regulatory affairs and drug development, particularly within rare diseases. + Basic… more
- Regeneron Pharmaceuticals (Tarrytown, NY)
- …typical day might include the following:** + Coordinate the preparation, submission, management and maintenance of global regulatory submissions related to ... The Senior Manager, Regulatory Affairs will report to the Global ...novel therapeutics including quality, preclinical and clinical areas of drug development and the policies/procedures required to ensure compliance… more
- Sanofi Group (Cambridge, MA)
- …planning activities, including generating submission content plans, submission tracking, and document management utilizing the support and input of ... **Job Title:** Regulatory Strategist **Location** : Cambridge MA/ Morristown, NJ...of medicine? The race is on to speed up drug discovery and development to find answers for patients… more
