Lupin Pharmaceuticals (Company Headquarters)

Regulatory Affairs Associate

Job Locations US-MD-Baltimore
Posted Date 4 weeks ago(1/24/2018 3:10 PM)
Job ID
2018-2248
# of Openings
1

Overview

This role majorly will involve on the coordination of the promotional materials review process through the Promotional material committee along with maintenance of  regulatory databases, maintaining a filing and documentation system, scheduling meetings, preparing for payment of invoices, coordinating paperwork associated with contracts and completing routine regulatory filings.

Responsibilities

  • Acts as a liaison/coordinator with marketing product managers/brand agencies to ensure timely review of marketing materials.
  • Coordinate and organize promotional review meetings whenever needed.
  • Maintain RA databases and files.          
  • File, organize and retrieve submissions related documentation from regulatory archives.
  • Maintain spreadsheets and tracking systems as required. Update and maintain templates and SOPs for regulatory submissions.
  • Aid regulatory affairs team in activities such as cover letter and form preparations associated with regulatory submissions.
  • Facilitate payments needed for submissions, establishment registrations, export certificates, consultants, purchase of supplies and other regulatory activities.
  • Support the FDA submissions through ESG gateway.
  • Monitor, track and log invoices through SAP. Ensures expenses are documented accurately.   Work with accounting department to ensure invoices and credit card expenses are accurately coded
  • Supports the coordination of conference calls, meetings, and events
  • Acts as a liaison with Marketing Product Managers to ensure timely review of marketing materials.

 

Qualifications

  • Bachelor’s Degree in a scientific area
  • 2-3 years of strong administrative experience, that includes technology, communication, organization, time management and planning skills.
  • Strong organizational skills with the ability to keep others organized and meet all deadlines
  • Demonstrated ability to learn & process new information quickly
  • Robust communication and analytical skills.
  • Attention to detail and quality
  • High degree of demonstrated proficiency with Excel, Word and PowerPoint
  • Ability to shift priorities and change directions frequently throughout the day
  • Ability to work with multiple top priorities, and requests from Sales and Marketing
  • Advanced computer skills & ability to conduct research through the internet

 

 

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