| The Director, Commercial Regulatory Affairs (CoRA) will provide strategic input into the review and approval of effective yet FDA compliant commercial (advertising and promotion) campaigns and pre-commercialization activities. This job serves as the regulatory lead on Copy Review Committees (CRCs), which they will Chair, and on the respective Product Medical Review Committees (PMRC). |
The Director, Commercial Regulatory Affairs will lead the Oncology Business Group (OBG) Commercial Regulatory Affairs function which is responsible for managing the advertising and promotion material review and approval process through all product CRCs and the FDA submission process for branded materials.
Responsibilities include but are not limited to:
1. Serving as CRC Chair to moderate purposeful discussions in a solution-orientated and time-sensitive manner, swiftly leading the committee to consensus on the approval of materials or the need to escalate, ensuring that CRC members uphold the Eisai values during CRC meetings and other CRC-related activities, and fostering close collaboration with the Business Owner to optimize the quality of the materials and accelerate their review and approval.
2. Ensuring highly effective and efficient review and approval process for advertising and promotion materials and the timely and accurate submission of branded materials to FDA in compliance with FDA regulations
3. Leading the development of best practices and procedures for CRCs including the maintenance of the CRC SWP to ensure the consistency, accuracy and quality of the advertising and promotion review and approval process.
4. Ensuring a robust training program on the advertising and promotion review and approval process is implemented for all CRC stakeholders, as well as support training on the regulatory requirements for advertising and promotion review and approval and the regulatory landscape.
5. Reviewing and approving all advertising and promotional materials, concept reviews and pre-commercialization materials for assigned products in collaboration with commercial, clinical and legal to ensure that they comply with FDA regulations. Providing strategic input into labeling as a member of core labeling development teams.
6. Acting as liaison with OPDP for assigned marketed products to facilitate the FDA review of advertising and promotional materials (e.g. launch materials submitted for advisory).
7. Providing legal, clinical and commercial with updates on new FDA guidance, the issuance of enforcement letters by OPDP and other Eisai or competitor product FDA correspondence.
8. Developing, implementing and maintaining regulatory procedures regarding review of advertising and promotional materials for marketed products and pre-commercialization materials for products or uses prior to FDA-approval.