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Regulatory Project Manager
Biologics Consulting Group, Inc. has an opportunity for a highly motivated Regulatory Project Manager (RPM) with previous drug development experience in the pharmaceutical or biotech industry. This position involves working as a consultant directly with biopharmaceutical companies to provide regulatory services. The RPM is mainly responsible for interacting with clients, Subject Matter Expert (SME) Senior Consultants, affiliates and internal team members. KEY ACCOUNTABILITIES Advise clients on current FDA regulations, policies, and guidance applicable to CDER and CBER. Provide regulatory strategy for FDA meetings and applications. Manage FDA submissions of Meeting Requests and Briefing Packages, INDs, BLAs, NDAs, ODDs, DMFs & all re


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