Clinical Regulatory Affairs Career Research and Resources
Western Institutional Review Board
Handled inbound communications (approximately 80-120 calls per day) Worked primarily with sponsors, CROs and SMOs with my task to resolve the issue without transfereing to another department. Primary inquiries were related to status of review process and documentation, facilitation of problem resolution.
Avg. Salary: $69,000 · Company Rank: Not Available
International Technidyne Corp
Senior Scientist with a distinguished twenty-plus year professional career in planning and project-managing testing and quality management initiatives supporting the development of medical devices and diagnostic assays. Industry background supplemented and enhanced by experience in educating students. Core competencies include: • Verification/Validation Studies • Resource Allocation • Project Management • Study/Master Tes...
Avg. Salary: $75,000 · Company Rank: Not Available
Beckman Coulter
Managed all aspects of product development, regulatory approval and commercialization of molecular-based in-vitro diagnostic devices for Beckman's Iris Molecular Diagnostics division.
Avg. Salary: $150,000 · Company Rank: Not Available
Accenture
Review and quality control of regulatory submissions for federal and global requirements. Assurance that submissions are eCTD submission ready for the FDA's Electronic Submission Gateway. Project management of original INDs, sNDA, and their respective lifecycle management amendments and supplements.
Avg. Salary: $67,500 · Company Rank: Not Available
Torrent Pharmaceuticals Limited
Regulatory submission
Avg. Salary: $0 · Company Rank: Not Available
Mylan Laboratories Limited
•Preparing and reviewing CTD dossiers (eCTD) for generic product submission adhering to the Quality standards and the requirements of the respective Health Agencies. •Uploading the e CTD dossier in Documentum Compliance Manager (DCM) and linking in eCTDXPress. •Ensure timely submission of variations. •Coordinating with colleagues in EU/AUS/NZ/RSA to ensure submission of quality response to regulatory queries on new product...
Avg. Salary: $0 · Company Rank: Not Available
Genpact Pharmalink
• Managed a team of contractors involved in a multi-phased global project for 17 months. • Managed a second team of contractors strictly involved in quality assurance on all work performed during the project. • Actively engaged with Project Lead to establish strategy and ensure deliverables and timelines are met. • Project encompassed several key deliverables: • Liaise with client’s local country offices to determine and a...
Avg. Salary: $104,000 · Company Rank: Not Available
Unigene Laboratories Inc.
• Assigned lead role to author and compile two CMC Drug Substance Type II DMFs following FDA and ICH guidelines by liaising with various departments within the company. • Successfully authored and compiled CMC Drug Product section in the eCTD format for a client’s Phase I IND submission by interfacing with various departments both within the company and with client personnel for a solid oral dosage form. • Participated in...
Avg. Salary: $104,000 · Company Rank: Not Available
Unigene Laboratories Inc.
Oversee the planning, design, execution, assessment, and documentation of analytical method development and validation experiments using a wide variety of analytical instrumentation and techniques to meet regulatory requirements. Lead method development and validation projects and Quality Control project teams of up to 4 people. Troubleshoot analytical method and instrumentation problems, write and revise analytical procedu...
Avg. Salary: $104,000 · Company Rank: Not Available
Liquent, A Parexel Company
Provide basic paper and electronic publishing services including document preparation, scanning, word formatting, rendering, bookmarking, hyper linking, compilation, table of contents creation, volumizing submission, pagination, and formatting of reports and simple submissions. Maintain familiarity with current global regulatory submission standards. I have gained regulatory knowledge as well as publishing tools expertise....
Avg. Salary: $0 · Company Rank: Not Available
