Manager Regulatory Submissions
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Employment Type: Full Time
Experience: 5 years or more
Full-Time Salary Range: $80,000 to $115,000
Job Description: Provide regulatory expertise to project teams in submission activities related to executing regulatory strategies. This facilitates US product marketing and compliance with regulations. Is the regulatory expert on project teams, counseling on applicable regulations/guidance related to submissions to ensure that submissions are complete and accepted by the Food and Drug Administration (FDA). Knows the FDA guidelines to determine submission content and communicates to the project team these requirements to ensure the execution of regulatory strategies. Prepares and submits documents to regulatory agencies in a format accepted by FDA. Evaluates potential impact and communicates current governing regulations/guidance to project teams for submission related activities. Interfaces with departments for submission related activities (Medical/Clinical, GPSSI, Marketing, Legal, Marketing). Maintains submissions file room in accordance with regulatory and legal requirements, as well as corporate standards for records retention to ensure that the business is not "at risk". Supervises contract/temporary staff for short term assigned projects.
Qualifications: Strong computer background. Specifically extensive electronic publishing experience (e.g. CoreDossier) and proficient with extensive knowledge/expertise in Microsoft WORD, PowerPoint and Excel. Previous Regulatory experience specifically related to INDs/NDAs/ANDAs/CTD/eCTD content and organization. OTC regulatory experiences a plus. Knowledge of good documentation practices. Well organized and detailed-oriented. Ability to multi-task, prioritize under tight timelines and work independent of direct supervision. BS/BA College and/or 6-10 years pharmaceutical experience required.