and immune disorders. Summary The Associate Director of Regulatory Writing is a key role responsible for producing... at the study team level. The Associate Director of Regulatory Writing must possess advanced knowledge of BLA/MAA submissions...
Associate Director is accountable for operational planning and execution at the study level with responsibility for clinical... submission. The Associate Director will have routine interaction with key internal and external stakeholders communicating...
development plan to ensure the study designs at each phase of the development are scientifically sound, can fulfill regulatory... input for the interaction or by writing the interaction document. May participate in meeting or teleconferences with Health...