This position will be responsible for the execution and reporting of clinical trial activities, ensuring adherence to study timelines, budgets, quality plans, and relevant ICH/GCP Guidelines. This position will report to the Vice President, Clinical Operations
The Director of Regulatory Affairs is intended to play a key role in the development of regulatory strategy and the plan for implementation for all products under development. This individual will also be responsible for overseeing the implementation of that plan. This role is the primary interface with global health authorities and represents the company in such interactions, along with relevant business leads. The individual will engage external consultants appropriately to develop the plan, working alongside internal and external stakeholders to ensure maximum and efficient value creation through creative and appropriate regulatory strategies.