Director Respiratory Bioequivalence Strategy Lead
Core
Leads bioequivalence strategy for respiratory product development programs to ensure regulatory compliance and optimize in-vivo performance.
Role type
Director, Respiratory Bioequivalence Strategy Lead
Builds
Respiratory generic and brand medicines
Domain
Healthcare / Pharma / Respiratory Therapeutics
Required skills
Bioequivalence strategy, in-vitro/in-vivo relationship analysis, regulatory submission authoring, analytical methodology development, pre-clinical and clinical study design, statistical tool application, inhaled product development knowledge, biopharmaceutics expertise, cross-industry regulatory engagement, technical mentoring
Preferred skills
None stated
Technologies
None stated
Responsibilities
Lead bioequivalence strategy input to project teams; partner with pre-clinical and clinical leads to define required studies; generate high-quality technical reports interpreting scientific outcomes; make technical recommendations on product development and regulatory objectives; brief managers and present data at technical meetings; write regulatory correspondence and represent the company at regulatory authority meetings; collaborate with statistics SMEs on methodologies; maintain awareness of scientific and regulatory developments; mentor individuals on bioequivalence principles; contribute to strategic and operational development of group capabilities.
Seniority
Director, strategic leadership with hands-on technical execution