Performs eCTD submission management across Biogen's 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 Biogen 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.
...
Company Description Founded in 1943, Little Falls Alloys, Inc. is a premier manufacturer of precision wire products, proudly serving global industries from our headquarters in Paterson, New Jersey. We specialize in drawing high-performance wire from materials such as...
Position Overview We are looking for a skilled and compassionate Nephrologist to join our team. This role involves diagnosing, treating, and managing a broad spectrum of kidney-related conditions, including chronic kidney disease (CKD), end-stage renal disease (ESRD...
...Business Managers (CBM). This role has responsibility for achieving aggressive annual sales, profit, and growth goals by selling Honeywell products, services, and capabilities. You will be responsible for managing a distinct set of strategic customers, long term exclusive...
Job Title: Java Architect (Contract) Location: Fremont, CA (Hybrid) Duration: Contract Job Description: We are looking for an experienced Java Architect to lead the design and development of scalable, high-performance enterprise applications. The ideal candidate...
...licensed and unlicensed staff who provide direct support and care to Upward Healths patients. The Patient Access Respresentative is a remote role, responsible for managing a large volume of inbound and outbound calls in a timely manner, effectively addressing patient...