Associate Regulatory Operations
Abbott Laboratories
Job Title: Associate Regulatory Operations
RA Function: Document Operations
Job Responsibilities:
The Associate Regulatory Operations is responsible for processing of submission documents, use of document management tools, perform quality checks on own and other team members' to ensure compliance with Abbott/Regulatory Authority formatting standards.The individual needs to work effectively with Operations team members, Regulatory colleagues and Publisher to assure high quality documents and to meet established deadlines of submission packages.The Individual must have excellent written & oral communication skills in English & be able to work with business partners globally.The individual will also perform other regulatory operations activities as needed.The individual supports departmental projects and less experienced colleagues.The individual contributes in settings standards and developing training materials on document operations activities.The individual contributes in process improvement, system enhancement, and provide assistance in troubleshooting issues with software and processes.Minimum Education and/or Equivalent Experience and/or Other Experience/Training Required for this Job Role:
Life Sciences Graduation or above3-5 years Regulatory experience or 3-5 years in R&D or related areaFamiliarity with pharmaceutical regulatory or labelling documents.Verbal and written communication skills.Experience with MS Word formatting.Document management experience.Ability to quickly learn, and use document management based computer systems.Must be process oriented with a strong attention to detail.Ability to work in a fast paced team environment and re-prioritize work to meet business needs.
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