Regulatory Strategy
- Develop product-specific regulatory strategies, including determination of the need and timing of regulatory authority interactions
- Create meeting requests and briefing documents for FDA meetings (e.g., EOP1, EOP2, pre-NDA/BLA and pre-sNDA/sBLA, and other Type A, B, or C meetings) and CHMP requests for scientific advice
- Assimilate
multiple inputs into documents that articulate client’s position to
worldwide health agencies in support of development and registration
strategies for pipeline projects
- Research worldwide regulatory precedents that set the stage for how clients should be positioning the pipeline moving forward, for internal strategic decision making and in dialog with regulatory agencies in closed and open meetings
- Prepare strategy for meetings with regulatory agencies
- Represent clients during interactions with regulatory agencies
- Create global regulatory strategy plans for pipeline products, incorporating feedback from key stakeholders
- Work cross-functionally with study teams to design Phase 1-3 and PMC trials
- Prepare sample size and power calculations
- Serve as member of Data Monitoring Committees (DMCs) and Steering Committees
- Create interim reports for DMCs
- Perform analyses for clinical study reports (CSRs), scientific presentations, and publications
- Provide
statistical input to the design and development of product operating
plans, regulatory strategies, and commercialization strategies
- Create protocols, statistical analysis plans, charters (DMC, Steering Committee, IRC)
- Author replies to queries from regulatory agencies
- Write CSRs, integrated summaries, and other submission documents
- Act as an independent advisor to buy side and sell side analysts on regulatory, clinical, and statistical precedents for clinical development programs, registrational clinical trials, and FDA advisory committee meetings
- Assist analysts with pipeline valuations, including potential market sizes and approval probabilities
