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.