Regulatory Affairs Project Manager Job in Chicago, Illinois US
Reporting to the Regulatory Affairs Manager fora high volume manufacturer of bioequivalent generic pharmaceuticals and OTC specialty products.
Responsible for managing the regulatory aspects of projects/products, submission of correspondences and applications to regulatory agencies.
Direct liaison with regulatory authorities including review and approval application processes.
Working with a core team leading and participating in meetings by providing regulatory support to ensure compliance with all FDA requirements, provide product approval strategies.
Challenge is to work independently in a fast paced environment.
Background Required:
Writing of ANDAs (3 years)
CTD & ECTD & eDMS (3 years)
Generic Drugs (3 years)
Scientific Writing (3 years)
Direct experience working with regulatory agencies
Demonstrated strong project management, problem solving, negotiating
GLP and GMP
Excellent written and oral skill
Computer literate: Microsoft Excel, Word, PowerPoint, & Outlook
Location: Upper Midwest (relocation assistance)
Education: PhD with a minimum 2 years experience, MS with a minimum 4 years experience, or BS with a minimum 7 years experienceBackground Preferred (but not required):
RAC
Bi-lingual (Chinese or Indian)
Computer literate: Microsoft Excel, Word, PowerPoint, & Outlook Other Essential Abilities and Skills:
Results driven
Highly organized ability to multi-task
Ability to work independently as well as a team player
Business acumen
High energy & persistent
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