SheemazRaza

A botulinum toxin type A product faced a congested approval pipeline, with the standard market timeline significantly impacting launch timelines and revenue forecasts for the commercial team.

I led a full regulatory strategy redesign — restructuring the dossier to CTD format aligned with MOHAP's evolving requirements, identifying parallel review pathways, and maintaining active health authority dialogue throughout the process.

Three high-revenue aesthetics products required price resets to reflect updated global reference pricing and maintain profitability margins. EDE repricing submissions carry high evidentiary standards and require robust commercial justification.

I built the repricing dossiers from scratch — including comparative pricing analysis, market context documentation, and supporting clinical/commercial data packages — and managed the authority engagement process end-to-end.

Escalating HCP interaction volumes exposed gaps in documentation, approval workflows, and compliance tracking — creating regulatory and reputational risk across the region's commercial operations.

I led the evaluation, selection, and implementation of a dedicated HCP compliance software platform, building the governance framework, SOP architecture, and cross-functional change management process from the ground up.

Iraq and Lebanon presented significant regulatory complexity for product expansion — underdeveloped formal submission pathways, unpredictable authority timelines, and limited available guidance for multinationals.

I mapped the available regulatory entry routes for each market, designed dossier structures adapted to local requirements, and built the submission infrastructure that enabled the commercial team to activate both markets.