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Sr. Manager, Regulatory Operations - United States  

Intercept (company)


Posted on : 23 May 2017

Project Description

To perform this job successfully an individual must be able to perform each essential function satisfactorily. " Manages daily operational activities for preparation of global regulatory submissions (project management, resource scheduling, formatting, publishing, QC, archive and submission) " Collaborates with interdisciplinary teams, international colleagues, vendors and Regulatory Affairs in the management of submission components and tracking of deliverables " Ensure consistency, completeness, and adherence to agency guidelines, internal work instructions and SOPs " Ability to manage and prioritize multiple tasks in a fast-paced environment while keeping with submission timelines " Evaluate, author and review SOPs, Guidelines and Work Instructions to ensure regulatory documents, submissions, and systems are well-controlled and comply with applicable regulations " Operate as Subject Matter Expert in dossier types and/or processes with responsibility for training and mentoring fellow colleagues " Stay current with new electronic submission and regulatory documentation practices issued from global health authorities " Author, review and maintain training materials for Regulatory systems " Provide companywide individual and group training on EDMS " Review, test, and implement new software releases and upgrades " Assumes other relevant assignments as directed by the Head of Regulatory Operations QUALIFICATIONS: " Bachelor s degree preferred, or equivalent combination of education and industry experience. " 8 years experience in the pharmaceutical industry " 6 years Regulatory Operations experience " Experience with electronic submission building tools, document formatting and publishing standards " Experience using electronic document manager system REQUIRED KNOWLEDGE AND ABILITIES: " Experience with electronic regulatory submissions, associated publishing tools, templates, regulatory document control and management of EDMS " Strong technical aptitude, preferably with extensive exposure to Microsoft Word, Adobe Acrobat and the use of PDF Processing Tools (ToolBox) " Works under minimal direction and possess flexibility to work productively within an environment with evolving priorities and deadlines " Knowledge of the regulations and processes that govern content, maintenance, and submission of controlled documents required by regulatory authorities " Effective communication skills, both verbal and written " Exceptional attention to detail as well as organizational skills, including the ability to prioritize and multitask " May be required to work overtime in order to meet company deadlines, as needed

Locations

San Diego CA United States

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