Sr. Regulatory Affairs Associate Job Description

Sr. Regulatory Affairs Associate Job Description Template

Our company is looking for a Sr. Regulatory Affairs Associate to join our team.

Responsibilities:

  • Assist with the development of SOPs and Work Instructions to support compliance;
  • Provide functional area support as requested for specific projects;
  • Actively participate in evaluation of quality and regulatory compliance of document/ product/ process/ test method changes;
  • Provide regulatory support and guidance to R&D product development teams as well as Quality Assurance teams as required;
  • Maintain current knowledge of FDA and international regulations, guidances, and standards applicable to company products;
  • Maintain compliance with company’s retention and destruction policy;
  • Coordinate labeling development, reviews and approvals through the RA Labeling Group;
  • Provide labeling support for all marketed products under NDAs/BLAs and ANDA;
  • Author labeling sections for all NDA and contract manufactured ANDA’s Annual Reports;
  • Assist in the authoring, compilation, review and submission high-quality regulatory submissions to HAs in accordance with regulatory guidelines;
  • Support the Senior Labeling Manager with all SPL activities, as needed.

Requirements:

  • Experience working independently with minimal supervision;
  • Knowledge of regulations relating to prescription drug labeling/drug development are essential.