Regulatory Affairs Coordinator

This opportunity is with a LEADING global pharmaceutical company dedicated to eye health research. They are looking to add a Regulatory Specialist to their team. This company has great culture and is rapidly growing! They are looking to interview as soon as this week!

Description:

Responsible for the review and evaluation of all FDA submissions to assure accuracy and completeness of submission documents for IND/NDA/ANDA products.

Responsibilities:

• Determines submission requirements and requests needed data, information, and documentation from pertinent departments, facilities, and affiliates, and from contractors/vendors as needed. Liaises with partner companies as appropriate.
• Reviews and provides comment for reports and amendments to INDs/NDAs, assuring submission within specified regulatory timeframes. Reviews and provides comment for accuracy and completeness all materials to be included in submissions, including materials prepared by others and supplied to Regulatory.
• Responsible for preparing Regulatory Module 1 documents, including labeling markups and annotations for submission.
• Interacts with all department, facilities, and affiliates with regard to investigational and marketed products for required information and documentation.
• Contributor for regulatory guidance regarding investigational and marketed products (U.S. and Canada).
• Advises Regulatory Management of any delays in submissions or potential regulatory problems for investigational and marketed products (U.S. and Canada).
• Performs other projects, project-based tasks and/or special projects as assigned by Regulatory Management.

Additional Skills & Qualifications:

• 2-4 years of prior regulatory affairs experience
• Basic module 1 authoring experience
• MS office proficiency
  • You will need experience with word for forms/cover letters
  • Use excel for project tracking
  • Use Teams for project management
• Project tracking and data entry
  • Project management system they use is Smartsheets
    • Insert data for submissions, view the dashboard to search countries and products, change dates and countries, assigning task, gathering information for projects. 
• Excellent communication and verbal skills
• Authoring experience for letters and forms
  • 1572 forms, 356H forms, cover letters