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Chicago

Regulatory Operations Specialist

JOB SUMMARY:

The Regulatory Operations Specialist is an entry-level role within the Compliance team. The Regulatory Operations Specialist provides support for the Regulatory department to ensure efficient and compliant business processes, practices, and workflows aligned with pharmaceutical industry standards, working across various clients for a fast-paced digital agency.
This individual will work closely with internal teams to champion a compliant workplace. This individual will use their knowledge and skills to maintain and improve the quality of work delivered, as well as promote professional skill growth within the company.
 
RESPONSIBILITIES:
  • Upload all client project assets from initial to final stages into client MLR (medical, legal, regulatory) systems
  • Review client project asset annotations for color, placement, and verbiage accuracy to ensure client guidelines are being followed
  • Assist in the maintenance of regulatory folder structure as well as all other organizational systems that will be utilized within the regulatory department
  • Attend and participate in regulatory meetings and reviews
  • Utilize knowledge and experience to identify and tackle challenges within the regulatory area
  • Provides recommendations and support to the eg+ Regulatory Ops team
  • Provides support for tools that manage submissions and notifications of changes, among others
  • Determine and communicate submission and approval requirements
  • Assist in preparation and review of regulatory submissions to authorities
  • Provide feedback and guidance as needed to ensure the highest quality of deliverables

QUALIFICATIONS:
REQUIRED:
  • Bachelor’s degree in related field or HS Diploma
  • Two or more years of relevant experience in a similar role
  • Excellent verbal and written communication skills
  • Must have computer literacy to operate standard word processing, spreadsheets, presentations, and internet applications
  • Experience with document metadata
  • Experience with annotations (both Functional and Primary)
  • Experience with document attachments (Medical references, back-up documentation, etc.)
  • Comments (red boxing)
  • Google Docs
  • Adobe Acrobat
  • Able to sit in front of a computer for long stretches of time
PREFERRED:
  • At least three years of experience in Regulatory Affairs for Pharma
  • Understanding of FDA regulations and pertinent state and federal laws governing pharmaceutical products manufacturing and marketing
  • Binder submission regulations (as needed)
  • Non-Binder submission regulations
  • Veeva System experience
  • FUSE System experience
  • Jira experience
  • Slack/Teams experience

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 Designory is proud to be an Equal Employment Opportunity Employer. Designory does not discriminate on the basis of race, religion, disability status, protected veteran status, sexual orientation, or any other characteristic protected by federal, state or locallaws.