Division/Organization:
Position Purpose
This role works within a team to create Regulatory Agency Submission Packages (Dossier) using a number of build and publishing tools. The Dossiers are compiled in paper and/or electronic format with documentation received from Submission co-ordinators and submitted to Regulatory agencies (often within very tight timelines) to seek clinical trial and/or marketing authorization approval for pharmaceutical products.

Primary Responsibilities
? Responsible for the building, publishing, archiving activities and associated tasks for assigned Regulatory submissions within agreed timelines.
? Adhering to quality control procedures and standards related to submission publishing.
? Adhering to the appropriate use of document management systems, publishing and validation tools, through the use of working practices and quality control steps to ensure Regulatory compliance.
? Support other team members with submission workload when necessary to provide flexible support for the submissions portfolio.
? Support global/local teams by completing tasks assigned by submission co-ordinators
? Adhere to Pfizer compliance standards.

Technical Skill Requirements
? Computer literacy in MS Word/Outlook/Excel/Adobe Acrobat.
? Proven technical aptitude and ability to quickly learn and use new software, regulations and quality standards
? Functional and technical knowledge and skills to do the job at a high level of accomplishment

Qualifications (i.e., preferred education, experience, attributes)
? Proven technical aptitude
? Quick learner with ability to multi-task
? Ability to work with accuracy and attention to detail
? Ability to work with autonomy and/or part of a team in a busy environment
? Demonstrated ability to work in a highly regulated environment
? Demonstration of experience working in a customer service environment