arrow-down icon arrow-expand icon arrow icon icon-checkmark icon icon-facebook icon icon-instagram icon icon-linkedin icon icon-twitter icon play-btn icon
Chicago

Regulatory Operations Coordinator

JOB SUMMARY:
 
The Regulatory Operations Coordinator is a team-lead role within the Compliance team. The Regulatory Operations Coordinator 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 may execute tasks and generally exercise influence at the account level while working closely with internal teams and external clients to champion a compliant workplace. This includes assisting in creating, executing, and maintaining documentation and guidelines for regulatory and compliance processes and procedures aligned with the standards outlined internally, by brand guidance, and brand industries. This individual will use their knowledge and skills to mentor and guide members of the Compliance team to maintain and improve the quality of work delivered, as well as promote professional skill growth within the company.
 
RESPONSIBILITIES:
  • Serve as primary back-up for the Regulatory Operations Manager
  • Serve as one of the points of contact for all Regulatory resource requests for annotations, asset review, quality assurance, production/design, and proofreading
  • Work with discipline leads to ensure placement of resources and monitor timelines
  • Review all regulatory agency compliance materials to guarantee accuracy, timeliness, comprehensiveness, and obedience to regulatory standards
  • Review and prepare all client project assets from initial to final stages for upload to client MLR (medical, legal, regulatory) systems
  • Review client project asset annotations for color, placement, and verbiage accuracy to ensure client guidelines are being followed

  • Work closely with Pharma account leads, MLR, and brand champions
  • Attend and participate in regulatory meetings and reviews
  • Work with Project Managers to provide an overview of regulatory processes and any necessary onboarding materials
  • Assist in designing and coordinating the preparation and ongoing review of policies, procedures, training materials, and other communication tools to ensure departments meet compliance requirements
  • Build out client-specific regulatory documentation to assist in training/development of the Regulatory department
  • Assist in coordinating rollout and training of new or updated policies and directives when required
  • Assist in developing strategies to ensure regulatory compliance
  • Utilize knowledge and experience to identify and tackle challenges within the regulatory area
  • Provide recommendations and support to the eg+ Regulatory Ops team
  • Provide 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
  • Assist compliance with product post-marketing approval requirements
  • Assist in the review of advertising and promotional items
  • 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

_______________________________ 

 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.