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Job Field: Government Jobs
Location: SALT LAKE CITY, UT
Job Type: Full Time

JOB SUMMARY:

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Under general direction, functions as primary regulatory contact with regulatory authorities for assigned products and projects. Manages preparation of regulatory submissions, briefing packages and presentations for regulatory agency meetings. Determines nature, scope and format of information to be generated in order to successfully: file and maintain INDs/CTAs; file regulatory dossiers; respond to health authority inquiries; maintain product registrations and obtain international market access. Manages preparation of briefing and presentation materials for regulatory agency meetings.Essential functions include: * Carries out managerial responsibilities in accordance with the organizationamp;apos;s policies, procedures, and applicable state federal and local laws. * Functions as primary contact with regulatory authorities for assigned products and projects. Prepares and issues Regulatory Agency Telephone Contact Reports and Meeting Minutes. *Prepares and/or reviews regulatory submissions (i.e., NDAs, amendments, supplements, annual reports, etc.) to regulatory agencies. * Determines nature, scope and format of information to be generated in order to successfully: file and maintain INDs/CTAs; file regulatory dossiers; respond to health authority inquiries; and obtain market approval for development product candidates. * Works with Regulatory Operations to track, compile, and review regulatory submissions for accuracy, completeness and quality. Informs management of deviations from target timelines. *Interacts with various departments as needed on regulatory issues and/or strategy. Effectively guides, communicates and implements determined strategy with the appropriate departments and/or employees. *Interacts with the FDA to facilitate approval of regulatory submissions. *Maintains awareness of regulatory activities on assigned projects. Works to minimize regulatory issues and helps prevent unnecessary regulatory delays. *Interacts with outside partners and consultants as needed. * Manages response team for regulatory agency inquiries. * Administers preparation of briefing and presentation materials for Regulatory Agency meetings. * Drafts product labeling and manages product labeling teams. * Represents department on project teams for assigned products/projects. *Provide training and coaching to increase employee knowledge, skills, and development. Generate guidelines and procedures to facilitate an understanding of and compliance with department practices. * Ensures project deadlines and performance standards are established and met. * Ensures compliance with all Company policies and procedures, including safety rules, federal, state and local laws regulations. * Performs related duties as assigned.Six (6) years relevant work experience; or equivalent combination of education and experience. Knowledge of: * Regulatory environment, regulatory submission and/or pharmaceutical healthcare environment. * Business and personal computer hardware and software applications. * Business English usage, spelling, grammar and punctuation. * Supervision and training practices and methods. * Current Company policies, practices and procedures, including safety rules and regulations.Bacheloramp;apos;s Degree in related field from an accredited college or university; Masteramp;apos;s Degree preferred.

KEY REQUIREMENTS:

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High School Diploma