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Sr. Manager, Regulatory Operations San Diego 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 company-wide 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 

  • 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

  •  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


San Diego CA United States

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