Director Respiratory Bioequivalence Strategy Lead
Core
Lead respiratory product development programs to ensure they meet regulatory bioequivalence requirements through strategic study design and technical optimization.
Role type
Director, Respiratory Bioequivalence Strategy
Builds
Respiratory generic and complex product development programs
Domain
Healthcare / Pharma / Respiratory / Bioequivalence
Required skills
Bioequivalence strategy, In-vitro/in-vivo relationship analysis, Regulatory submission authoring, Analytical methodology development, Pre-clinical and clinical study design, Inhaled product development knowledge, Biopharmaceutics expertise, Cross-industry regulatory forum engagement, Technical report generation, Statistical methodology application
Preferred skills
Mentoring scientific teams, External representation at regulatory authority meetings, Strategic capability development
Technologies
Analytical tests, Statistical tools, Regulatory submission platforms
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 activities; Provide briefings to 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 developments and regulatory guidance; Contribute to cross-industry working groups; Mentor individuals on bioequivalence tests.
Seniority
Director, strategic leadership & mentorship