ASSOCIATE DIRECTOR, REGULATORY AFFAIRS – IRVINE, CA
Oversee and manage regulatory activities and drive project time lines to coordinate the compilation, review and submission process for ANDA’s and subsequent amendments. Interact and communicate with the FDA from product inception to approval, including regulatory. Support during pre-approval inspections for assigned projects. Oversee and manage all rems regulatory activities. Provide strategic regulatory input for product issue resolution, coordinate, prioritize, and provide day-to-day regulatory support. Provide strategic Position/landscape for new products. Identify and reduce internal/external barriers to accelerate the approval process. Advise project teams and regulatory department members of potential areas of concern and new governmental and regulatory developments. Responsible for the final review of department submissions and provide technical input and present regulatory strategy. Assist with the final review of other department submissions, as well as, with decision making on complex CMC issues. Communicate with R&D formulations, technical operations, analytical R&D, manufacturing, quality control, quality assurance and internal audit group throughout the development and submission process to ensure all submission related documents (batch manufacturing and control records, packaging records and analytical reports) are assembled and reviewed on an ongoing basis, with problems identified and addressed concurrently. Serve as Regulatory representative to assigned project teams and interact with corporate partners in order to achieve common goals. Review change requests as well as associated documentation and provide effective regulatory strategy. Utilize and remain current with Internal/external electronic submission initiatives.
Must have Master of Science degree in regulatory affairs. Must have two (2) years of experience serving in a position Manager, Regulatory Affairs. Must have experience in filing ANDA’s and serve as FDA point of contact; reviewing CMC sections of ANDA; monitoring, reviewing and signing annual reports; ensuring labels and packaging comply with FDA and trademark laws. Must be a Certified Regulatory Affairs Professional (RAC-US). 40 hours per week, M-F 9:00am-5:00pm. Must have proof of legal authority to work in the United States. Mail resume to HR at Anchen Pharmaceutical, Inc. 9601 Jeronimo Road, Irvine, CA 92618. Please reference job #20180707