Senior Regulatory Affairs Associate – Langhorne, PA

Summary:

To offer regulatory guidance and advise to project teams and preparation and review of content for regulatory submissions.

JOB RESPONSIBILITIES:

  • Prepare and submit eCTD submissions for generic and new drug development projects and marketed products to ensure timely submissions to the FDA (Original Applications, Amendments, Supplements, and Annual Reports).
  • Interpret FDA Guidances and advise stakeholders such as R&D, Operations, and Business Development.
  • Prepare and assist submitting Drug Listing and SPL/PLR submissions
  • Manage electronic submissions to FDA in eCTD format.
  • Review change control documents, batch records, and other technical documents
  • Coordinate and work with Regulatory/R&D colleagues for the preparation of regulatory submissions
  • Keep current with existing/pending regulations and FDA Guidances for generic drugs and new drugs to ensure compliance with Regulatory Agency requirements.
  • Participate in the development and maintenance of Regulatory Operations systems, processes, checklists and procedures to facilitate consistency.
  • Organize and maintain Regulatory application records and indices in the Regulatory Operation Center
  • Prepare and review labeling and promotional materials for submission to the Regulatory Agency
  • Maintain GDUFA Self-Identification status and update annually
  • Assist in annual GDUFA User Fee payments
  • Maintain/update Facility Establishment Registration status
  • Maintain and renew other permits and licenses
  • Assist in authoring and finalizing departmental SOPs

ESSENTIAL JOB REQUIREMENTS AND QUALIFICATIONS:

  • Must have experience with the ANDA submission process from start to completion
  • SPL labeling experience is a plus
  • Proficiency in eCTD publishing software is a must
  • Excellent attention to details
  • Excellent verbal and written communication skill
  • Good understanding of regulatory requirements for ANDAs and 505b(2) applications
  • Good knowledge of FDA guidelines, 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 with some guidance
  • Ability to multi-task
  • Ability to establish and maintain good working relationship
  • Pre- and post-approval experience is highly desired
  • Knowledge in Pharmacovigilance

EDUCATION AND EXPERIENCE:

  • Bachelor's Degree in Scientific discipline
  • Minimum 5 years' experience in the Generic Pharma industry
  • Previous R&D (analytical or formulation) experience is a plus
  • 505b(2) experience is a plus

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.