Associate Regulatory Operations

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 above
• 3-5 years Regulatory experience or 3-5 years in R&D or related area
• Familiarity 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.