Regulatory Affairs Associate III #RAA1121AS
Teva Pharmaceuticals USA, Inc. has an opening for the position of Regulatory Affairs Associate III (Ref# RAA1121AS).
Work Location: 400 Interpace Pkwy., Parsippany, NJ 07054.
Job Duties:
Lead and manage Food & Drug Administration (FDA) submissions through the regulatory approval process, including preparation of original Abbreviated New Drug Applications (ANDAs), amendments, supplements, annual reports, and related correspondence to the FDA, in order to obtain timely approvals. Represent the Regulatory Affairs department through interactive communication with various internal and external stakeholders. Responsible for evaluating change controls to provide accurate regulatory filing assessments in accordance with applicable guidance documents. Accurately populate and maintain associated databases and trackers in real time. Independently review and prepare regulatory submissions for drug products under development and review by the FDA. Interface with R&D on a regular basis to ensure project-specific regulatory strategy is met. From regulatory point of view continually assess the product development process and reports and provide feedback to R&D on the ANDA projects assigned. Initiate regulatory strategy on CMC (Chemistry, Manufacturing & Controls) Regulatory Affairs issues throughout the drug development process. Serve as a regulatory knowledge base by continually working with R&D on ANDA projects and documenting the regulatory strategy on several milestones, such as Quality Target Product Profile (QTPP) / Critical Quality Attributes (CQA), composition, product and process design, various specification settings, manufacturing, stability design, and stability data analysis. Coordinate responses to the FDA with appropriate personnel and departments to resolve outstanding regulatory filing issues. Coordinate, prepare, and review responses to FDA deficiencies to secure timely approvals. Keep current with the FDA/ICH guidance and regulations pertaining to Generic Drug User Fee Amendments (GDUFA), CMC, and regulatory filing aspects. Approve Inactive Ingredient Guide (IIG) ingredients and assure that they are in accordance with the FDA database. Assess change controls in accordance with FDA guidance documents and review/approve with the system.
Manage the preparation for FDA meetings and provides strategic guidance on the organization of these meetings. Coordinate, prepare, and review post-approval regulatory submissions (ANDA supplements, deficiency responses) for applications, in accordance with project timelines. Provides regulatory training to the department on an as-needed basis.
Requirements:
This position requires a Bachelor's degree or foreign academic equivalent in Regulatory Affairs, Pharmaceutics, Pharmacology, or a related field. Plus 3 years of experience in the job offered or 3 years in a related pharmaceutical regulatory occupation. Will accept a Master's degree plus 1 year of experience in lieu of the required education and experience. Position requires 6 months of experience with FDA submissions (amendments, supplements & annual reports), ANDAs, and GDUFA. Will accept any suitable combination of education, training, or experience as per the requirements cited herein. 40 hours/week.