The Senior Director of Regulatory Affairs is responsible for establishing regulatory direction and providing management support for the US development of complex Inhalation products within Lupin’s complex portfolio
Job Summary
The Senior Director of Regulatory Affairs is responsible for establishing regulatory direction and providing management support for the US development of complex Inhalation products within Lupin’s complex portfolio.
This individual is responsible for guiding and coordinating with R&D and HORA, reviewing ANDAs pre- or post-submission, proactively working with cross-functional teams, including marketing, to resolve any outstanding issues identified, and ensuring timely, high-quality submissions to focus on first-cycle approvals.
The candidate will get involved in the early stages of product development to ensure that the ANDAs with good experience in Complex Products have sufficient information to support a quicker approval.
Matching Summary
The Senior Director of Regulatory Affairs is responsible for establishing regulatory direction and providing management support for the US development of complex Inhalation products within Lupin’s complex portfolio.