Performs eCTD submission management across the companies product portfolio to Health Authorities for global development and lifecycle management submissions. The Regulatory Operations Manager is responsible for the coordination of all publishing deliverables, in line with the strategic direction of their assigned programs/products. Oversee outsourced publishing deliverables on a day-to-day basis to ensure successful execution of operational activities for assigned products.
Acts as the primary point of contact for regulatory functions as appropriate in the products lifecycle. The Regulatory Ops. Manager ensures submission deliverables are incorporated and visible to all stakeholders. Ensures hand offs and deliverables from authoring community are on time and in line with the submission standards and expectations of quality. Drives deliverable timelines with RSM (RA Regulatory Submission Manager) and authoring community and sets appropriate standards and expectations of quality. Responsible for electronic submissions and documents meeting regulatory agency and the companies submission standards and technical requirements. Quality control checks on electronic common technical (eCTD) components, final submissions, hyperlinks and bookmarks, and ensures submissions adhere to local health authority guidelines. Demonstrates expert knowledge of submission or technology-related Health authority guidelines/regulations. Competent in the use of electronic document management and submissions publishing tools. 3-5 years of experience in regulatory operations providing submission delivery support for the US and Europe. Experience overseeing publishing vendors preferred. Pay ranges between $58-65.50/hr based on expereince...reports and performs basic analysis of a limited range of clinical data. Summarizes data and provides information to department manager... ...empower patients and families to focus on health, healing and recovery.__You will do this by executing against our three experience pillars...
...Are you a data-driven digital marketer who thrives on optimizing performance and uncovering actionable... ...Team Collaboration: ~ This is a full-time, in-office role based in Lincoln,... ...initiative, accountability, and shared wins. Part of your time will also be spent...
...be part of an inclusive, adaptable, and forward-thinking organization, apply now. We are currently seeking a Front End Full Stack Developer (Onsite Hybrid) to join our team in Boston, Massachusetts (US-MA), United States (US). Basic Qualifications: 5+ years...
...per referral!~401k with employer match ~ Attentive & Supportive Leadership! We can work with your scheduling needs: All shiftsinclude rotating weekends plus some holidays Part Time Day & Evening Shifts - VariedShifts No late nights! How you will...
...your information by visiting and logging into the careers section of the system.**Job Description:**At Regions, Business Unit Change Management Partner plans, assesses, manages, and monitors change management efforts and ensures the division is prepared for such changes...