Senior Regulatory Affairs Associate – Bristol, PA

Summary:

To offer regulatory guidance to project development and manufacturing teams on preparation and review of regulatory submissions.

JOB RESPONSIBILITIES:

  • Prepare and submit e-CTD ANDA, CBE-0, CBE-30, PAS, Annual Reports
  • Interpret FDA guidances and advise R&D, Operations, Business Development
  • Review change control, batch records, annual reports and CMC documents
  • Coordinate work with CMO, Regulatory/R&D teams on regulatory submissions
  • Keep current with FDA regulations and guidances for generic drugs
  • Participate in development of regulatory operations systems
  • Maintain regulatory submissions and regulatory communication records
  • Assist with submission of the annual GDUFA User Fee payments
  • Maintain Facility Establishment Registration status
  • Assist in authoring and finalizing regulatory SOPs
  • Review CMC section of drug product labeling
  • Interact with CRO on drug safety reporting

ESSENTIAL JOB REQUIREMENTS AND QUALIFICATIONS:

  • Must have hands-on experience with ANDA submission process
  • Proficiency in e-CTD publishing software is necessary
  • Excellent attention to CMC details
  • Clear verbal and written communication skills
  • Good understanding of regulatory requirements for ANDAs
  • Good knowledge of FDA,ICH and related guidelines
  • Demonstrates a basic understanding of pharmaceutical drug development.
  • Proficiency in Microsoft Office and XML programs
  • Ability to manage timelines and priorities
  • Ability to work independently and with some guidance
  • Ability to multi-task and adopt to changing priorities
  • Ability to establish and maintain good working relationship
  • Pre- and post-approval CMC experience is highly desirable

EDUCATION AND EXPERIENCE:

  • Bachelor’s Degree in scientific discipline
  • Minimum 5 years of regulatory experience with generic drugs
  • Previous CMC experience is required

For more information about career opportunities with Virtus, or to send us a copy of your resume, please email jobs@virtusrx.com and reference the position name in the subject line.